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MedWorm: Aortic Stenosis News



MedWorm.com provides a medical RSS filtering service. Thousands of medical RSS feeds are combined and output via different filters. This feed contains the latest news in Aortic Stenosis



Last Build Date: Sat, 14 Apr 2018 01:27:40 +0100

 



JenaValve Is a Growing Force to be Reckoned with in TAVR

Wed, 11 Apr 2018 06:03:14 +0100

It would be a big mistake to leave JenaValve out of the transcatheter aortic valve replacement (TAVR) market conversation. The Munich, Germany-based company has been biding its time and reaching milestones, in the hopes of obtaining some serious market share in the TAVR space. The small company's latest achievement is successfull enrollment in the CE mark study of the next generation of JenaValve Pericardial TAVR system. “It’s very tricky to develop a TAVR system because it can take several iterations before you can get it right,” Victoria Carr-Brendel, JenaValve CEO, told MD+DI. “We think we have achieved in just a couple of generations of this transfemoral system, a viable device that actually gets it right.” The company will submit for CE mark sometime in the second quarter...

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NOTION: 5-Year TAVR vs SAVR Outcomes Similar in Low-Risk Patients NOTION: 5-Year TAVR vs SAVR Outcomes Similar in Low-Risk Patients

Mon, 09 Apr 2018 14:01:59 +0100

All-cause mortality, MI, and stroke were similar in low-risk patients with severe aortic stenosis who had transcatheter aortic valve replacement and those who had surgery, but 42% of TAVR patients needed pacemakers.Medscape Medical News (Source: Medscape Medical News Headlines)



Edwards Eyes Delay for its Sapien 3 Ultra TAVR

Thu, 22 Mar 2018 17:55:22 +0100

Edwards Lifesciences said it is delaying the launch of the Sapien 3 Ultra transcatheter aortic valve replacement (TAVR) System in Europe until later this year. The Irvine, CA-based company said it would refocus on commercialization efforts after it submits data from the 30-patient, single-arm study of the device treating patients at intermediate risk from surgical valve replacement. The study data would help supplement the company’s bid to gain CE mark for the technology. Edwards said the updated timing for the European launch of the Sapien 3 Ultra doesn’t change the company’s sales guidance for 2018 and that it still continues to expect the U.S. introduction of the device in late 2018. The Sapien 3 Ultra System features an on-balloon design that is intended to streamline procedures...



Colibri Course Corrects to be Relevant in TAVR

Mon, 19 Mar 2018 20:48:36 +0100

Colibri Heart Valve LLC has started a feasibility study of its second-generation transcatheter aortic valve replacement system that will treat patients with severe aortic stenosis. The Broomfield, CO-based company said it has treated two patients in the study with its redesigned valve. “We spent the last three years modifying our product because the market has changed so drastically from 2012, in both patient indications and also bicuspid valves,” Joseph Horn, president and CEO of Colibri Heart Valve, told MD+DI. “We decided that the product we had was probably not going to be robust enough to satisfy the patient demands. We hired the right engineers. We redesigned the frame and we actually remodified the tissue so that it’s robust. We’re able to address the market as it stands t...



TAVR Reasonable for Low-Flow, Low-Gradient Aortic Stenosis (CME/CE)

Mon, 19 Mar 2018 18:00:00 +0100

(MedPage Today) -- Low 30-day mortality observed in high-risk group (Source: MedPage Today Surgery)



Medtronic and Edwards Duel in TAVR Space

Tue, 13 Mar 2018 19:59:46 +0100

A pair of studies support the long-term use of Medtronic’s CoreValve transcatheter aortic valve replacement (TAVR) system. The Dublin-based company unveiled results from both the Nordic Aortic Valve Intervention Trial (NOTION) and the CoreValve U.S. Pivotal Extreme Risk Study at the American College of Cardiology 67th Annual Scientific Session (ACC) this past weekend. NOTION is a physician-initiated trial that studied an all-comers population of 280 patients at least 70 years old. Patients in the trial were randomized to either Surgical Aortic Valve Replacement (SAVR) or TAVR procedures. Join us at the BIOMEDevice Boston Expo,  April 18–19, 2018. Use promo code "MDDI" for 20% off conference registration and free expo access.   Results at five-year follow-up from NOTION showed simi...

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Edwards Adds Bold New Chapter to TAVR Story

Thu, 15 Feb 2018 23:02:38 +0100

Edwards Lifesciences just might have leaped-frogged over some of its competitors in the burgeoning  TAVR market. The undisputed TAVR pioneer has received CE mark for its Centera valve to treat severe, symptomatic aortic stenosis patients at high risk of open-heart surgery. The Edwards Centera valve is repositionable and retrievable and can be delivered through a low-profile, 14-French, motorized delivery system. The company said the device is packaged with the valve fully pre-attached to the delivery system, which helps with simple and rapid device preparation. Network with your colleagues in medtech at ADM Cleveland, March 7–8, 2018.  “We think today’s approval augments the firm’s momentum in the TAVR market,” said Jason Mills, an analyst with Canaccord Genuity. CE mark for...



Edwards Lifesciences wins CE Mark for Centera TAVR

Thu, 15 Feb 2018 14:57:00 +0100

Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its self-expanding transcatheter Centera aortic heart valve, with indications for treating symptomatic aortic stenosis patients at high risk of open-heart surgery. The Centera valve is designed to be repositionable and retrievable, and is delivered through the use of a 14 French motorized delivery system in which the valve is pre-attached to the mechanism for quick preparation, the Irvine, Calif.-based company said. “With the Edwards Centera valve, European clinicians and their patients may now benefit from a self-expanding TAVR option that has demonstrated exceptional clinical safety and performance outcomes in the high surgical risk population. Enhanced design features of the Centera valve...



The Future of TAVI The Future of TAVI

Thu, 25 Jan 2018 05:02:32 +0100

While TAVI has emerged as the established therapy for patients with severe, symptomatic aortic stenosis, there are still challenges that remain, and improvements that can be made.European Heart Journal (Source: Medscape Today Headlines)



Cardiac Amyloid Buildup Not Uncommon In TAVR Patients

Mon, 22 Jan 2018 20:35:00 +0100

(MedPage Today) -- Study opens question of interaction between aortic stenosis, amyloid (Source: MedPage Today Cardiovascular)



Ashfield are shortlisted for a PM Award

Thu, 18 Jan 2018 09:11:19 +0100

Ashfield Digital & Creative, alongside our colleagues at Watermeadow Medical and our clients at Edwards Lifesciences, are thrilled to announce that we have been shortlisted for a PM Society Award in the Primary Care Campaign category for ‘Listen to the Heart’. A campaign focused on the lifesaving opportunity available to GPs through the early identification of aortic stenosis. Speaking about the collaboration, which led to this campaign, Ashfield Digital & Creative Senior Vice-President Andrew Binns said, “This entry demonstrates the impact that can be achieved when strategic insights and creative come together. This project was a brave and exciting approach to communications and it would not have been possible without our clients Dirk Iden and his fantastic team from Edward...

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Edwards Lifesciences recalls Certitude delivery device for Sapien 3 valve

Thu, 11 Jan 2018 17:50:08 +0100

Edwards Lifesciences (NYSE:EW) is recalling the Certitude delivery device used with its Sapien 3 replacement heart valve on the risk that a molding defect could embolize, the FDA said today. The Sapien 3 is a transcatheter aortic valve replacement designed to treat aortic stenosis. During implantation the valve is crimped to Certitude’s balloon before either transapical or transaortic insertion into the body. The recall, of some lots made between Nov. 22, 2016, and July 10 of last year, is due to a molding overflow defect in the button valve within Certitude’s loader, according to the federal safety watchdog. The risk is that the overflow material could detach and embolize into the patient. Edwards warned customers of the issue last July, asking them to check their inventory f...



3 Reasons TAVR Will Continue to Prosper

Tue, 09 Jan 2018 19:49:57 +0100

The transcatheter aortic valve replacement (TAVR) market has already seen rapid growth, and today represents a $3 billion market globally. But the leading TAVR companies say the current technology and approved indications barely scratches the surface in terms of the true growth potential of the space. Michael Mussallem, CEO of Edwards Lifesciences, told J.P. Morgan Healthcare Conference attendees on Monday that the global TAVR market is expected to exceed $5 billion by 2021, and that number does not include certain indications that are currently being explored, like treatment for patients with asymptomatic aortic stenosis (AS) or moderate AS. Several experts from Edwards Lifesciences will speak at the MD&M West Conference, February 6-8, 2018, in Anaheim, CA. Register now using the pr...



Impaired Survival With LVEF < 60 Percent in Aortic Stenosis

Fri, 05 Jan 2018 01:00:00 +0100

Poorer outcomes seen for LVEF (Source: Pulmonary Medicine News - Doctors Lounge)



' Normal' LVEF: Misnomer in Aortic Stenosis?

Wed, 27 Dec 2017 18:00:00 +0100

(MedPage Today) -- Study shows survival in severe aortic stenosis impaired with LVEF (Source: MedPage Today Cardiovascular)



Can Boston Scientific Bounce Back from Lotus Setback?

Wed, 29 Nov 2017 16:19:11 +0100

Boston Scientific shares took a beating Tuesday after the company abruptly backed out of a scheduled appearance at the annual Piper Jaffray healthcare conference in New York. As investors seemed to fear, the sudden change of plans foreshadowed another Lotus setback. The company's stock (NYSE: BSX) dropped 7.5% by market close on Tuesday, slashing Boston Scientific's market cap by about $2.9 billion. About three hours after the close, the company said it had pushed back its previously-reported timelines for re-introducing the Lotus Edge aortic valve system in Europe, and the filing of a final pre-market approval (PMA) module with FDA. The Lotus Edge for transcatheter aortic valve replacement (TAVR) may be one of the most watched products in Boston Scientific's pipeline. The device has drawn...

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Boston Scientific takes a $3B hit on latest Lotus valve delay

Wed, 29 Nov 2017 13:47:57 +0100

Boston Scientific (NYSE:BSX) saw its market capitalization lose $3 billion after yesterday revealing another delay for its Lotus replacement heart valve. The Marlborough, Mass.-based company, which recalled the Lotus transcatheter aortic heart valve in February over issues with its locking mechanism, said it no longer expects the ensuing manufacturing and design specification changes to get the valve back on the market in Europe or allow the final filing in its pre-market approval bid with the FDA by January 2018. “We continue to see value in the unique benefits of the LOTUS Valve platform in treating patients with aortic stenosis,” chairman & CEO Mike Mahoney said in prepared remarks. “While we are disappointed in this delay to our timelines, we are working to caref...



Afternoon open heart surgery 'leads to fewer complications'

Fri, 27 Oct 2017 17:00:00 +0100

Conclusion This study found evidence of an effect that's worth investigating further to see if there are real differences in heart muscle function and risk of complications from heart surgery at different times of the day. However, there were some limitations: It took place at a single hospital, with a relatively small number of people undergoing operations. The laboratory study found differences in gene activity that suggested the body clock may play a role in making the heart better able to tolerate loss of oxygen and subsequent re-oxygenation. However, there may be other explanations for these differences. For example, all the operations were performed by only four different surgeons. Variation in post-operation outcomes could have something to do with the surgeons' performances rather ...



RAS Blockade After TAVI Tied to Better Outcomes (CME/CE)

Thu, 26 Oct 2017 17:00:00 +0100

(MedPage Today) -- Patients with severe aortic stenosis see reduced all-cause mortality (Source: MedPage Today Nephrology)



All-Time High for Obesity; Aortic Stenosis AUC; Prognosticating Cardiac Arrest

Fri, 20 Oct 2017 16:35:02 +0100

(MedPage Today) -- Cardiovascular Daily wraps up the top cardiology news of the week (Source: MedPage Today Pediatrics)



TAVR Looms Large in First AUC Document for Severe Aortic Stenosis TAVR Looms Large in First AUC Document for Severe Aortic Stenosis

Fri, 20 Oct 2017 16:13:25 +0100

There are more treatment options than ever before, but guidelines only go so far when the patient is 90-something, frail, and with multiple chronic disorders, for example.Medscape Medical News (Source: Medscape Medical News Headlines)

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Appropriate Use Criteria Developed for Aortic Stenosis Tx

Wed, 18 Oct 2017 17:00:00 +0100

SAVR or TAVR appropriate for most patients with symptomatic AS at intermediate or high surgical risk (Source: Pulmonary Medicine News - Doctors Lounge)



First Appropriate Use Criteria for Severe Aortic Stenosis Published (FREE)

Wed, 18 Oct 2017 00:00:00 +0100

By Kelly Young Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM The American College of Cardiology, the American Heart Association, and nine other medical groups have issued the first-ever appropriate use criteria for treating severe aortic stenosis.The … (Source: Physician's First Watch current issue)



First Appropriate Use Criteria Issued for Severe Aortic Stenosis

Tue, 17 Oct 2017 18:45:00 +0100

(MedPage Today) -- Multi-society guide OKs intervention for most symptomatic cases (Source: MedPage Today Primary Care)



Shockwave Medical raises $35m for Lithoplasty devices

Tue, 10 Oct 2017 14:47:08 +0100

Shockwave Medical said today that it raised another $35 million for the Lithoplasty devices it’s commercializing to treat blocked arteries. Fremont, Calif.-based Shockwave said it plans to use the new funding, which was led by new backer Fidelity Management & Research, to commercialize its existing devices for treating coronary and peripheral vessels in the U.S. and Europe and to evaluate the Lithoplasty tech in treating aortic valve stenosis. T. Rowe Price Assoc. also participated in the financing, which Shockwave said was an extension of its $45 million Series C round. The Lithoplasty devices are designed to use sound waves to break up calcified lesions blocking blood vessels. Shockwave said a first-in-human study of the technology showed that it’s be feasible for trea...



Medtronic launches post-market study of CoreValve Evolut Pro heart valve

Thu, 21 Sep 2017 15:04:38 +0100

Medtronic (NYSE:MDT) said today it launched a post-market clinical study of its CoreValve Evolut Pro valve, looking to evaluate performance out to 5 years for the self-expanding transcather aortic valve implantation system. The multi-center, prospective single-arm study aims to enroll 600 patients across 35 European sites to evaluate the safety of the CoreValve Evolut Pro, including all-cause mortality and all stroke at 30 days and clinical performance including valve hemodynamics and paravalvular regurgitation. “We look forward to replicating the excellent clinical outcomes demonstrated by the Evolut Pro valve in a study designed to look at the valve’s longer-term real-world performance. The Evolut PRO has shown exceptional results for patients with severe aortic stenosis and...

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Medical societies expand collaboration on cardiac registry

Tue, 19 Sep 2017 07:00:00 +0100

The American Society of Nuclear Cardiology (ASNC) and the American Society...Read more on AuntMinnie.comRelated Reading: ASNC, SNMMI advise on cardiac sarcoidosis ASNC releases guidance on MPI in women ASE: Echo protocol finds kids' heart abnormalities Echo groups release guidance on aortic stenosis Echo groups release new stress echo guidelines (Source: AuntMinnie.com Headlines)



Regular Evaluation Improves Survival in Asymptomatic Severe AS Regular Evaluation Improves Survival in Asymptomatic Severe AS

Mon, 18 Sep 2017 20:57:08 +0100

Patients with asymptomatic severe aortic stenosis followed according to guideline recommendations were more likely to undergo early valve replacement and had improved survival and reduced hospitalization.Medscape Medical News (Source: Medscape Radiology Headlines)



New educational resource to help GPs detect aortic stenosis early

Thu, 14 Sep 2017 10:22:53 +0100

A new interactive educational resource for GPs has been launched to support the early detection of aortic stenosis. (Source: GP Online News)



Do You Listen to Heart Sounds? This May be Another Reason Why You Should.

Tue, 12 Sep 2017 21:06:00 +0100

I’m not sure about you, but when I went to school to become a paramedic (and a nurse for that matter), one thing I never really understood was heart sounds, or heart tones, depending on who taught you. My attempt at learning resorted to scouring textbooks, journals, online editorials, watching clips on YouTube and listening… lots of listening to sound bites from CDs. You know the ones, they come free when you buy a new stethoscope. Instead of turning to digital media, I should’ve been listening to the hearts of my patients. Hindsight is 20/20, especially in this case. All my self-guided education yielded few results, which was discouraging, to say the least. Because of this, I let it slip from my list of competent skills. That is, until I took care of Henry. Henry is a 68-year-old ge...



Tall VTE Risk; Frequent Aortic Stenosis Checks;'Sweet Spot' for LVAD Volume

Fri, 08 Sep 2017 16:30:00 +0100

(MedPage Today) -- Cardiovascular Daily wraps up the top cardiology news of the week (Source: MedPage Today Cardiovascular)

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Close Watch on Aortic Stenosis May Improve Outcomes

Thu, 07 Sep 2017 13:18:59 +0100

(MedPage Today) -- Single-center study supports guideline-based serial evaluations for asymptomatic patients (Source: MedPage Today Cardiovascular)



Serial Echos Valuable in Patients with Asymptomatic Severe Aortic Stenosis (FREE)

Thu, 07 Sep 2017 00:00:00 +0100

By Kelly Young Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, DFASAM Patients with asymptomatic severe aortic stenosis who don't get regular evaluations are at increased risk for death and heart failure, according to a retrospective study in … (Source: Physician's First Watch current issue)



Not adhering to recommended exams for severe narrowing of the aortic valve associated with increased heart failure

Wed, 06 Sep 2017 04:00:00 +0100

(The JAMA Network Journals) Patients with asymptomatic severe aortic stenosis who did not follow recommended guidelines for regular exams had poorer survival and were more likely to be hospitalized for heart failure, according to a study published by JAMA Cardiology. (Source: EurekAlert! - Social and Behavioral Science)



Intervention for Aortic Stenosis: Frailty Matters Intervention for Aortic Stenosis: Frailty Matters

Mon, 04 Sep 2017 05:14:43 +0100

The FRAILTY-AVR study evaluated different frailty scales in predicting poor outcomes following TAVR and SAVR. What did we learn and how will it influence clinical practice?Journal of the American College of Cardiology (Source: Medscape Today Headlines)



Nonagenarians'Good Candidates' for TAVI Surgery Nonagenarians'Good Candidates' for TAVI Surgery

Fri, 01 Sep 2017 18:10:22 +0100

Severe aortic-stenosis patients aged 90 years or older can be candidates for transcatheter aortic-valve implantation, with similar outcomes to those in younger patients, researchers say.Medscape Medical News (Source: Medscape Medical News Headlines)

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Cardiopulmonary Exercise Testing Prognostic in Aortic Stenosis

Fri, 25 Aug 2017 00:00:00 +0100

Conservative strategy results in good prognosis if CPET does not indicate hemodynamic compromise (Source: Pulmonary Medicine News - Doctors Lounge)



Next-gen Repositionable Self-expanding Catheter Safe for Severe Aortic Stenosis Next-gen Repositionable Self-expanding Catheter Safe for Severe Aortic Stenosis

Mon, 14 Aug 2017 19:54:35 +0100

The self-expanding, repositionable Evolut R transcatheter heart valve (THV) from Medtronic appears safe and effective for treating older patients with severe aortic stenosis, according to a company-funded observational study.Reuters Health Information (Source: Medscape Today Headlines)



Medtronic wins FDA nod, CE Mark for Avalus aortic valve

Wed, 02 Aug 2017 16:15:11 +0100

Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union and FDA approval in the US for its Avalus pericardial aortic surgical valve designed to treat aortic valve disease. The Avalus is the Fridley, Minn.-based company’s next-gen pericardial surgical aortic valve, and features a supra-annular design to improve hemodynamic performance and limit central regurgitation. The valve also features interior-mounted leaflet and frame design for improved durability and a low-profile design with a streamlined valve holder and single, one-cut release for easier implantations, Medtronic said. “Medtronic is committed to advancing its surgical portfolio to offer cardiac surgeons a contemporary option to help meet the individual needs of this patient population. By contin...



Medtronic touts reduced costs, rehospitalizations in cryoballoon vs RF AF ablation trial analysis

Tue, 01 Aug 2017 15:58:26 +0100

Medtronic (NYSE:MDT) today released data from a health economic analysis from the Fire And Ice trial comparing its Arctic Front cryoballoon catheter to its ThermoCool radiofrequency ablation cath, touting that cryoballoon treatment could reduce costs and rehospitalizations when used to treat paroxysmal atrial fibrillation. Economic analysis results from the trial were published today in the Journal of the American Heart Association. Researchers analyzed data from the 769-patient trial, which Medtronic claims is the largest to compare cryoballoon ablation to point-by-point RF ablation for treating paroxysmal AF, originally presented last year, exploring cost differences between patients treated with either RF or cryoballoon. Results indicated cost savings of approximately $925 per patient...



Medtronic wins CE Mark for CoreValve Evolut Pro

Mon, 31 Jul 2017 15:24:55 +0100

Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its CoreValve Evolut Pro transcatheter aortic heart valve, indicated for the treatment of severe aortic stenosis for symptomatic patients at intermediate, high or extreme risk for open heart surgery The CoreValve Evolut Pro features an outer wrap to add surface area contact between the valve and the native aortic annulus to increase valve sealing performance, Fridley, Minn.-based Medtronic said. “We are excited to introduce the next evolution of our Evolut TAVI platform to provide physicians in Europe with a comprehensive portfolio to address their patients’ needs,” heart valve therapies GM Rhonda Robb said in a press release. Medtronic said that the clearance was supported by data from a c...

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Experience Journal: A bereaved mother ’s lessons from the heart

Thu, 27 Jul 2017 15:50:42 +0100

Jessica Lindberg’s son Ethan was a brave heart warrior whose journey at Boston Children’s Hospital began before he was even born. At 20 weeks, they learned he had aortic stenosis and evolving hypoplastic left heart syndrome (HLHS). At 22 weeks Ethan was the 30th baby to have an in-utero procedure to open his aortic valve and relieve pressure in the left side of his heart. By the time Ethan was 2, he’d had four open-heart surgeries. He was also having feeding problems, developmental delays, and was struggling with executive functioning and spatial tasks. Like many other parents of children with congenital heart defects (CHD), Jessica wanted Ethan to thrive as well as survive — to make sure he had the skills to eat, walk, grow and socialize. A referral to Dr. Janice Ware in the Car...



3D printing helps evaluate leaks after TAVR procedures

Wed, 26 Jul 2017 07:00:00 +0100

3D-printed phantoms of aortic root anatomy offer a noninvasive way to assess...Read more on AuntMinnie.comRelated Reading: Echo groups release guidance on aortic stenosis ACC: CT detects blood clots that reduce valve motion CT better than echo for aortic annulus before TAVR Study finds differences in CCTA plaque measurements Cutting-edge techniques transform practice of cardiac CT (Source: AuntMinnie.com Headlines)



Stress Echo Value Questioned for Asymptomatic Aortic Stenosis

Wed, 26 Jul 2017 00:00:00 +0100

Neither increase in mean pressure gradient, systolic pulmonary artery pressure predicted outcome (Source: Pulmonary Medicine News - Doctors Lounge)



Morristown Medical Center Randomizes First Patient in World to New...

Thu, 13 Jul 2017 00:00:00 +0100

Morristown Medical Center Randomizes First Patient in World to New Study to Evaluate Treatment for Asymptomatic Severe Aortic Stenosis; Trial may change treatment paradigm, save heart muscle(PRWeb July 13, 2017)Read the full story at http://www.prweb.com/releases/2017/07/prweb14507855.htm (Source: PRWeb: Medical Pharmaceuticals)



Study: TAVR, surgical AVR results similar at 2 years in intermediate risk patients

Wed, 12 Jul 2017 17:48:15 +0100

Transcatheter and surgical aortic valve procedures were shown to have similar outcomes at 2 years in severe aortic stenosis patients deemed to be at intermediate surgical risk, according to a recently published study. Data came from a 2-year follow up with patients in the Partner 2 trial, which aimed to explore the difference between the 2 procedures in intermediate risk patients. A total of 2,032 patients were examined in the trial, which was randomly divided into 2 cohorts, with the 1st receiving Edwards Lifesciences‘(NYSE:EW) Sapien XT and the 2nd receiving a surgical AVR procedure. At 2 years, both disease-specific and generic health statuses showed significant improvements in both arms of the study. TAVR patients showed better health statuses than those treated with AVR at 1 mo...

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FDA Expands CoreValve TAVR Indication to Intermediate-Risk Patients FDA Expands CoreValve TAVR Indication to Intermediate-Risk Patients

Mon, 10 Jul 2017 20:06:26 +0100

The expanded indication to include treatment of patients with severe aortic stenosis at intermediate risk for surgery is based on the pivotal SURTAVI data reported this March.FDA Approvals (Source: Medscape Medical News Headlines)



FDA Gives Approval to Medtronic's CoreValve for Use in Patients at Intermediate Risk for Surgical Valve Replacement

Mon, 10 Jul 2017 19:40:00 +0100

Based on results from the landmark SURTAVI Clinical Trial, presented at the American College of Cardiology Annual Meeting in March, and published in the New England Journal of Medicine, the FDA has approved the CoreValve TAVR self-expanding platform for use in patients with severe and symptomatic aortic stenosis who are at "intermediate" risk for surgical valve replacement, defined as mortality>= 3% at 30 days. (Source: News from Angioplasty.Org)



FDA clears Medtronic ’ s CoreValve Evolut TAVR in intermediate risk patients

Mon, 10 Jul 2017 16:49:38 +0100

Medtronic (NYSE:MDT) said today it won expanded FDA approval for its CoreValve Evolut transcather aortic valve replacement platform, now indicated for patients with symptomatic severe aortic stenosis who are at an intermediate risk for open heart surgery. The Fridley, Minn.-based company said that patients at intermediate risk for open-heart surgery have a mortality risk of greater than or equal to 3% at 30 days following the procedure. “Patients at intermediate risk for open-heart surgery account for a large portion of the severe aortic stenosis population. We are delighted to take the self-expanding CoreValve Evolut platform to more patients with aortic stenosis who can benefit from this therapy,” Medtronic heart valve therapies biz GM Rhonda Robb said in a press release. M...



7 medtech stories we missed this week: June 9, 2017

Fri, 09 Jun 2017 19:59:47 +0100

[Image from unsplash.com]From 3M’s expanded 510(k) clearance for its Tegaderm dressing to Medtronic and Acacia burying the hatchet, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. InspireMD inks Taiwanese distro deal for CGuard InspireMD announced in a June 8 press release that it has signed a distribution deal with Lorion Enterprises. The deal will expand InspireMD’s global footprint and distribute its CGuard Embolic Prevention System (EPS) through the medical device distributor in Taiwan. 2. Active Implants launches NUsurface knee trial Active Implants announced that it has started its Safety Using NUsurface (SUN) trial in San Diego, according to a June 7 press release. The purpose of the clinical trial is to test the NUsurface Meni...



ASE: Echo protocol finds kids' heart abnormalities

Fri, 02 Jun 2017 07:00:00 +0100

A new echocardiography protocol can detect early functional abnormalities in...Read more on AuntMinnie.comRelated Reading: Digisonics readies upgrades for ASE 2017 Echo groups release guidance on aortic stenosis Echo groups release new stress echo guidelines ASE debuts new educational offerings ASE offers guide for childhood heart disease (Source: AuntMinnie.com Headlines)

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TAVR in the Care of Older Persons With Aortic Stenosis TAVR in the Care of Older Persons With Aortic Stenosis

Fri, 02 Jun 2017 05:14:57 +0100

This article reviews current literature on the safety and feasibility of transcatheter aortic valve replacement in the elderly, focusing on frailty as an aid to prognosis and decision-making.Journal of the American Geriatrics Society (Source: Medscape Today Headlines)



Robot hearts: medicine ’s new frontier

Tue, 23 May 2017 04:30:43 +0100

From bovine valves to electrical motors and 3-D printed hearts, cardiologists are forging ahead with technologies once dismissed as “crazy ideas”On a cold, bright January morning I walked south across Westminster Bridge to St Thomas ’ Hospital, an institution with a proud tradition of innovation: I was there to observe a procedure generally regarded as the greatest advance in cardiac surgery since the turn of the millennium – and one that can be performed without a surgeon.The patient was a man in his 80s with aortic stenosis, a narrowed valve which was restricting outflow from the left ventricle into the aorta. His heart struggled to pump sufficient blood through the reduced aperture, and the muscle of the affected ventricle had thickened as the organ tried to compensate. If left ...



High Risk of Clinical Events With Moderate Aortic Stenosis Plus LVSD High Risk of Clinical Events With Moderate Aortic Stenosis Plus LVSD

Fri, 12 May 2017 18:41:52 +0100

The combination of moderate aortic stenosis and left ventricular systolic dysfunction (LVSD) is associated with a high risk of heart failure hospitalization and death, researchers report.Reuters Health Information (Source: Medscape Radiology Headlines)



Princeton Baptist Medical Center offers new aortic procedure

Tue, 18 Apr 2017 18:34:57 +0100

Princeton Baptist Medical Center has performed the first surgery in the state using a new treatment for severe aortic stenosis. It's the first facility in the Southeast to offer the technology - a new transcatheter aortic valve replacement procedure with a self-expanding implant and advanced sealing. The newly FDA-approved CoreValve Evolut PRO TAVR is for symptomatic patients who are at high or extreme risk for open heart surgery. “One of our strongest areas of expertise is treating patients… (Source: bizjournals.com Health Care:Physician Practices headlines)



Conscious sedation is a safe alternative to general anesthesia for heart valve procedure

Tue, 11 Apr 2017 02:19:13 +0100

FINDINGSUCLA scientists have found that conscious sedation — a type of anesthesia in which patients remain awake but are sleepy and pain-free — is a safe and viable option to general anesthesia for people undergoing a minimally invasive heart procedure called transcatheter aortic valve replacement.In the study, patients who underwent conscious sedation had a similar rate of adverse events to those who underwent anesthesia, but those who were given conscious sedation had shorter stays in the intensive care unit (30 versus 96 hours for those with general anesthesia) and shorter hospital stays (4.9 days versus 10.4 days). The direct costs for their care were 28 percent lower, and almost all other medical costs were lower as well. In both groups, 1.5 percent of patients died during hospita...

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Echo groups release guidance on aortic stenosis

Mon, 03 Apr 2017 21:48:38 +0100

The European Association of Cardiovascular Imaging and the American Society...Read more on AuntMinnie.comRelated Reading: Echo groups release new stress echo guidelines ASE debuts new educational offerings ASE offers guide for childhood heart disease ASE elects new president ASE: Aortic flow rate predicts risk of heart failure (Source: AuntMinnie.com Headlines)



Medtronic Receives FDA Approval for CoreValve ™ Evolut™ Pro Transcatheter Valve with Advanced Sealing

Wed, 22 Mar 2017 17:50:00 +0100

Medtronic plc (NYSE:MDT) today announced FDA approval and U.S. launch of the CoreValve ™ Evolut™ PRO valve for the treatment of severe aortic stenosis for symptomatic patients who are at high or extreme risk for open heart surgery. The approval comes on the heels of new 30-day clinical data that was unveiled at the American College of Cardiology (ACC) 66th Annual Scientific Sessio n, which showed high survival, low rates of stroke, minimal paravalvular leak (PVL) and excellent hemodynamics for the self-expanding valve. (Source: News from Angioplasty.Org)



Medtronic wins FDA nod for CoreValve Evolut Pro

Wed, 22 Mar 2017 17:18:28 +0100

Medtronic (NYSE:MDT) said today it won FDA approval for its CoreValve Evolut Pro transcatheter arortic heart valve replacement designed for treating severe aortic stensosis. The newly cleared, next-gen CoreValve Evolut Pro features an outer wrap to add surface area contact between the valve and the native aortic annulus to increase valve sealing performance, Fridley, Minn.-based Medtronic said. “Medtronic remains committed to working with interventional cardiologists and cardiac surgeons to deliver solutions that address patient needs with the safety and performance profile they expect from Medtronic. We are excited to introduce the next evolution of our Evolut TAVR platform to provide physicians with a comprehensive portfolio to address their patients’ needs,” Medtronic ...



Self-expanding TAVR as good as surgery in intermediate-risk patients

Fri, 17 Mar 2017 14:24:22 +0100

Two-year data reveal no difference in the combined rate of stroke and death from any cause when comparing the use of self-expanding transcatheter aortic valve replacement (TAVR) with standard open-heart surgery in intermediate risk patients with severe aortic stenosis, according to research. (Source: ScienceDaily Headlines)



Sharing Mayo Clinic: Daughter?s persistence leads to life-threatening discovery

Sat, 04 Mar 2017 23:00:00 +0100

Morgan Burke spent years urging her father, Tony Burke, to make a doctor?s appointment. When Tony was 12 years old, he had open-heart surgery at Mayo Clinic to repair aortic stenosis. But as an adult, the 48-year-old avoided most medical care. ?I?m just that type. I don?t go to the doctor ever ? unless I?m [...] (Source: News from Mayo Clinic)



9 cardiology breakthroughs you need to know

Fri, 03 Mar 2017 18:10:09 +0100

[Image courtesy of Michela on Flickr, per Creative Commons 2.0 license]Cardiology breakthroughs couldn’t come soon enough because heart disease is the No. 1 killer of men and women in the U.S. About 610,000 Americans die of heart disease per year, and an additional 735,000 Americans suffer from a heart attack. The statistics terrify. About 610,000 Americans die of heart disease per year, and an additional 735,000 Americans suffer from a heart attack. High blood pressure, high cholesterol and smoking are some of the top risk factors for heart disease, and 47% of Americans have at least one of these risk factors, according to the CDC. About 1 in every 6 healthcare dollars is spent on cardiovascular disease, according to the U.S. Health and Human Services Department. A recent RTI Interna...



Aortic stenosis test for open heart surgery is inaccurate

Fri, 03 Mar 2017 17:26:30 +0100

[Image from the American Heart Association]An approved exercise test that determines whether people with aortic stenosis need open heart surgery has only 60% accuracy, according to a new study by the University of Leicester. Cycling on a stationary bike typically determines whether a person needs surgery. If the patient becomes breathless while cycling, it is typically recommended to have valve replacement therapy. Gerry McCann, professor of cardiac imaging and honorary consultant cardiologist at the University of Leicester Department of Cardiovascular Science, conducted the research and found that the exercise test is “highly inaccurate” and results in thousands of patients having to undergo surgery when it isn’t needed and costs nearly £75M, according to a news release. Get more ...



Intervention vs. Symptom-driven Management in Aortic Stenosis Intervention vs. Symptom-driven Management in Aortic Stenosis

Fri, 03 Mar 2017 10:29:39 +0100

How should asymptomatic patients with severe aortic stenosis be managed? Is early aortic valve replacement beneficial?Heart (Source: Medscape Today Headlines)



Analyst bearish on intermediate-risk TAVR uptake, but still sees market as positive

Thu, 02 Mar 2017 17:30:36 +0100

While transcatheter aortic valve replacement technologies are on target to becoming a $5 billion market by 2021, analysts believe the path to indications for intermediate risk patients may be slower than previously expected. The market has showed a “notable step down in projected TAVR volume growth” in a set of surveys from April 2016 to Jan 2017, according to Leerink Partner analyst Danielle Antalffy. After a discussion with 5 interventional cardiologists, Antalffy wrote in a letter to investors that they still considered TAVR to be “one of the more exciting new MedTech markets that will exceed $5B by 2021,” but with the caveat that the “ramp in intermediate risk may progress at a slower pace” than previously thought. Antalffy said that in conversations...

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Inaccurate heart test costing the NHS, says Gerry McCann

Mon, 27 Feb 2017 10:52:40 +0100

Professor Gerry McCann, a cardiologist from the University of Leicester, was behind research that found exercise testing for aortic stenosis has only a 60 per cent accuracy rate. (Source: the Mail online | Health)



Controversial test could be leading to unnecessary open heart operations

Fri, 24 Feb 2017 05:00:00 +0100

(University of Leicester) A University of Leicester researcher leads an aortic stenosis study. (Source: EurekAlert! - Medicine and Health)



Iron and Calcification in Aortic Stenosis Iron and Calcification in Aortic Stenosis

Wed, 22 Feb 2017 06:05:54 +0100

This article explores the mechanisms by which iron, which may accumulate in the aortic valve by means of intraleaflet hemorrhages, might influence development of aortic valve stenosis.European Heart Journal (Source: Medscape Today Headlines)



AHN enrolling patients in comparative heart valve replacement study

Mon, 23 Jan 2017 17:52:49 +0100

Allegheny Health Network is one of 60 sites nationwide actively enrolling patients in a trial to compare the efficacy of nonsurgical valve replacement in healthier patients who require medical intervention. Transcatheter aortic valve repair (Tavr), a five-year old procedure used to treat patients with aortic stenosis, is often recommended for older patients deemed too risky for traditional aortic valve replacement. Dr. Stephen Bailey, director of the division of cardiac surgery at Allegheny General… (Source: bizjournals.com Health Care:Biotechnology headlines)



Medtronic Announces CE Mark and European Launch of Recaptureable TAVI System Now Available for Severe Aortic Stenosis Patients with Large Anatomies

Tue, 17 Jan 2017 23:59:00 +0100

The new Evolut R 34 mm valve is approved for severe aortic stenosis patients who are at intermediate, high or extreme risk for surgery with an annulus size ranging from 26-30 mm. This large valve segment is estimated to account for approximately 20-25 percent of the eligible European TAVI patient population. Previously, some of these patients were unable to receive a TAVI due to the larger size of their native diseased aortic valve. (Source: News from Angioplasty.Org)

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Hands On Product Reviews January 2017

Fri, 30 Dec 2016 07:38:15 +0100

Improved Manikin Control Graphical user interface changed the way we interact with computers. Since the introduction of the Macintosh in 1984, all computers have become more intuitive and require less knowledge of computer code for the everyday user. Continuing the trend of easy use, the new SimPad Plus from Laerdal has increased the processor speed, improved WiFi connectivity and added a Bluetooth connection to increase the number of manikins the SimPad Plus can control. Running scenarios with manikins or standardized patients remains intuitive and allows the instructor to be in the room or in a vehicle throughout the simulation. The number of heart sounds has increased and includes: aortic stenosis, friction rub, Austin Flint murmur, diastolic murmur, systolic murmur, mitral valve prolap...



Medtronic Announces Reimbursement Approval and Launch of CoreValve ™ Evolut™ R System in Japan

Thu, 01 Dec 2016 18:45:00 +0100

Medtronic plc (NYSE: MDT) today announced it has received reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the recapturable, self-expanding transcatheter CoreValve ™ Evolut™ R System for patients with severe aortic stenosis (AS) unable to undergo surgery, and for whom treatment with transcatheter aortic valve implantation (TAVI) is determined to be the best option. This approval follows the Shonin approval from the MHLW the company received in November.U (Source: News from Angioplasty.Org)



For Aortic Stenosis, TAVR Shows Short-term QoL Benefit For Aortic Stenosis, TAVR Shows Short-term QoL Benefit

Mon, 07 Nov 2016 22:49:11 +0100

Quality-of-life scores improved over 1 month for TAVR patients, but only with transfemoral access, not transthoracic; but surgical-valve replacement patients caught up after a year.Heartwire from Medscape (Source: Medscape Cardiology Headlines)



Innovation seen in transcatheter aortic valve replacement

Mon, 31 Oct 2016 17:44:12 +0100

Great strides are being made in the treatment of heart disease with innovative new treatment options for valvular heart disease. Since 2007, I’ve had the privilege of serving on a team of Emory physicians that has helped revolutionize the treatment of severe aortic stenosis, leading the national effort to study and advance a new nonsurgical procedure called transcatheter aortic valve replacement or TAVR. Aortic stenosis is a dangerous heart condition that affects tens of thousands of Americans… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)



Edwards Lifesciences wins CE Mark for Inspiris Resilia aortic valve

Thu, 29 Sep 2016 15:18:40 +0100

Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its Inspiris Resilia aortic valve. The Irvine, Calif.-based company said the valve is the 1st in a “new class of resilient heart valves” which incorporate its Resilia tissue and features a Perimount Magna ease valve and VFit technology for future valve-in-valve procedures. “The Inspiris valve creates a new class of surgical valves and includes key patient-focused innovations, such as the resilient tissue and the VFit technology, to advance the treatment of patients with heart valve disease. In partnership with surgeons, Edwards is committed to developing differentiating technologies that set a new standard for surgical heart valves,” surgical heart valve therapy corp veep Be...

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Claret Medical files for FDA clearance for Sentinel cerebral protection device

Tue, 20 Sep 2016 17:52:26 +0100

Claret Medical said today that it filed an application with the FDA seeking 510(k) clearance for its Sentinel cerebral protection system designed for use during transcatheter aortic valve replacements. The Santa Rosa, Calif.-based company’s Sentinel device is designed to capture and remove embolic debris dislodged during TAVR procedures, which can enter cerebral circulation and can potentially lead to strokes. “Our contribution in building significant new science will help the rapidly growing TAVR field embrace the critical role of cerebral protection in all left heart and endovascular procedures. These studies incorporate a level of rigorous brain evaluation never before undertaken, including systematic and serial state-of-the-art 3-Tesla MRI neuroimaging of patients’ pre-...



MassDevice.com +5 | The top 5 medtech stories for September 19, 2016

Mon, 19 Sep 2016 19:00:34 +0100

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Edwards Lifesciences wins expanded CE Mark for Sapien 3 replacement heart valve Edwards Lifesciences said today that it won CE Mark approval in the European Union for an expanded indication for its Sapien 3 transcatheter aortic valve replacement. The expanded indication covers patients at intermediate risk for open heart surgery, Irvine, Calif.-based Edwards said. Last month the FDA also expand...



Edwards Lifesciences wins expanded CE Mark for Sapien 3 replacement heart valve

Mon, 19 Sep 2016 14:14:55 +0100

Edwards Lifesciences (NYSE:EW) said today that it won CE Mark approval in the European Union for an expanded indication for its Sapien 3 transcatheter aortic valve replacement. The expanded indication covers patients at intermediate risk for open heart surgery, Irvine, Calif.-based Edwards said. Last month the FDA also expanded the Sapien 3 indication to include intermediate-risk aortic stenosis patients. The device won its original CE Mark approval back in January 2014, with the U.S. federal safety watchdog following suit in June 2015. “This expanded intermediate-risk indication allows for the treatment of even more patients whose only previous option was an open-heart surgical procedure,” Dr. Helge Möllmann, of Dortmund, Germany’s St. Johannes Hospital, said in prep...



Boston Scientific wins CE Mark for Lotus Edge heart valve

Mon, 19 Sep 2016 10:40:52 +0100

Boston Scientific (NYSE:BSX) said today that it won CE Mark approval in the European Union for its Lotus Edge, the next generation of its transcatheter aortic valve replacement. Marlborough, Mass.-based Boston Scientific said it plans to make the Lotus Edge valve available to “select centers” in Europe, accelerating the growth of its commercial footprint “as physicians and centers become fully trained.” The original Lotus TAVR won a CE Mark back in October 2013. Like its predecessor, the Lotus Edge valve is designed to reduce the paravalvular leakage that plagued early TAVR devices, but its deliver catheter has a more flexible, lower-profile design and a “Depth Guard” feature designed to lessen the need for permanent pacemakers. “We are steadfast ...



FDA approves Intuity Elite rapid valve from Edwards Lifesciences

Mon, 15 Aug 2016 13:42:33 +0100

The FDA approved the Intuity Elite rapid deployment replacement aortic valve made by Edwards Lifesciences (NYSE:EW). Irvine, Calif.-based Edwards said the Intuity Elite valve is designed to create more time during the treatment of complex heart failure cases for procedures to treat other facets of the disease. It’s on the U.S. market now, the company said. The Intuity Elite valve won CE Mark approval in the European Union in April 2014. “U.S. approval of the Edwards Intuity Elite valve system is a significant milestone as this technology provides an advanced surgical treatment option for patients suffering from aortic valve disease,” surgical heart valve therapy VP Bernard Zovighian said in prepared remarks. “In partnership with surgeons, Edwards is committed to...

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TAVR: Study shows benefit of Claret Medical ’ s Sentinel cerebral protection device

Fri, 12 Aug 2016 20:34:08 +0100

A study released this week reported that the use of Claret Medical‘s cerebral protection device during transcatheter aortic valve implantation procedures in patients with severe aortic stenosis can reduce the number and volume of brain lesions. The study, which received funding from Claret and Medtronic (NYSE:MDT), was published in the August 9 issue of the The Journal of the American Medical Association. “First, as other studies have noted, emboli to the brain that cause infarction detected on MRI are very common with TAVI. In this trial, acute lesions on MRI were present in virtually all patients enrolled, although the vast majority of these lesions were quite small. Second, use of an embolic protection device can successfully reduce cerebral infarct number and volume. Wheth...



MassDevice.com +5 | The top 5 medtech stories for August 1, 2016

Mon, 01 Aug 2016 19:00:11 +0100

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. Haemonetics sees shares rise on Q1 release Haemonetics has seen shares rise despite releasing 1st quarter earnings that saw losses grow and earnings per share shrink compared to last year. The Braintree, Mass.-based company reported losses of $10.3 million, or 20¢ per share, on sales of $210 million for the 3 months ended July 2. Read more 4. Intersect ENT files with FDA for drug-delive...



CoreValve Evolut R First TAVR to Receive CE Mark for Intermediate Risk Patients

Mon, 01 Aug 2016 18:23:00 +0100

This morning Medtronic plc (NYSE: MDT) announced that its recapturable and repositionable CoreValve Evolut R System has received the CE Mark to treat patients with severe aortic stenosis who are at intermediate risk for open-heart surgery, making the CoreValve Evolut R the first TAVR device to obtain approval for this patient population. Previously TAVR devices were indicated for use only in patients at high risk for surgery. (Source: News from Angioplasty.Org)



Medtronic wins expanded CE Mark for Evolut R TAVR system

Mon, 01 Aug 2016 16:10:04 +0100

Medtronic (NYSE:MDT) said today it won expanded CE Mark approval in the European Union for its CoreValve Evolut R transcatheter aortic valve replacement, now approved for aortic stenosis patients at intermediate risk for open-heart surgery. The Fridley, Minn.-based company touted the win, saying it is the 1st TAVI system to have received expanded indication in Europe for patients at intermediate risk for open heart surgery. “The unique design of the self-expanding, supra-annular Evolut R System, coupled with its ability to be recaptured and repositioned for accurate valve placement, enables this device to be a viable treatment alternative for patients at intermediate surgical risk. The highly-anticipated intermediate risk indication marks an important milestone for the industry as w...



Simple risk score may aid TAVR candidate selection

Fri, 29 Jul 2016 05:28:09 +0100

A simple scoring system that takes comorbidity, frailty and disability into account can effectively stratify early and late mortality rates among extreme- and high-risk patients with aortic stenosis undergoing transcatheter aortic valve replacement, US researchers report. (Source: MedWire News)

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Clinical trial allows Abrazo Arizona to offer heart surgery alternative to low-risk patients

Thu, 21 Jul 2016 23:30:03 +0100

< img src="http://media.bizj.us/view/img/10093991/azheart-tavr-181931*100xx1501-1500-94-0.jpg" > As part of a nationwide clinical trial, Abrazo Arizona Heart Hospital will begin performing procedures on low-risk patients with complex heart conditions that would serve as an alternative to open-heart surgery. The hospital will be the first in Arizona to perform Transcatheter Aortic Valve Replacement (TAVR) procedures on low-risk patients suffering from aortic stenosis. Abrazo is one of 80 hospitals around the nation participating in the five-year-long clinic trial. “This is a very innovative… < div class="feedflare" > < a href="http://feeds.bizjournals.com/~ff/industry_6?a=EMpmViZGOmo:Z_nZ7bKbnB8:yIl2AUoC8zA" > < img src="http://feeds.feedburner.com/~ff/industry_6?d=yIl2AUoC8zA" borde...



‘Strikingly’ low 1-year mortality recorded for TAVR device

Thu, 14 Jul 2016 21:44:27 +0100

Findings from the PARTNER trial of the SAPIEN3 transcatheter heart valve system support the use of transcatheter aortic valve replacement as “the preferred therapy” in high-risk and inoperable patients with aortic stenosis. (Source: MedWire News)



Possible Cancer Finding on Pre-TAVR CT Doesn't Affect SurvivalPossible Cancer Finding on Pre-TAVR CT Doesn't Affect Survival

Fri, 01 Jul 2016 13:51:17 +0100

"The presence of malignancy may not necessarily be a contraindication to TAVR, since the life-limiting condition may be the aortic stenosis," said one expert. Heartwire from Medscape (Source: Medscape Medical News Headlines)



One-third of patients with low flow aortic stenosis do not improve with transcatheter aortic valve replacement, research finds

Wed, 15 Jun 2016 17:47:45 +0100

For patients with low flow aortic stenosis, TAVR -- a minimally invasive procedure which corrects the damaged aortic valve -- is often the best option for restoring the heart's normal pumping function. However, approximately one-third of these patients treated with TAVR continue to suffer persistent low flow AS. Researchers have examined this high-risk patient population to determine the cause and evaluate risk of mortality. (Source: ScienceDaily Headlines)

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TAVI, SAVR Outcomes Not Significantly Different in Short TermTAVI, SAVR Outcomes Not Significantly Different in Short Term

Fri, 10 Jun 2016 17:35:52 +0100

Early and midterm outcomes of transcatheter aortic valve implantation (TAVI) are not significantly different from those of surgical aortic valve replacement (SAVR) in patients treated for severe aortic stenosis, according to a new meta-analysis. Reuters Health Information (Source: Medscape General Surgery Headlines)



TAVI matches SAVR for early and midterm mortality

Wed, 08 Jun 2016 07:13:43 +0100

Transcatheter aortic valve implantation has similar early and midterm mortality to surgical aortic valve replacement in patients with aortic stenosis, including those at low to intermediate risk, show results of a systematic review and meta-analysis. (Source: MedWire News)



Should TAVR Be Performed in Nonagenarians?Should TAVR Be Performed in Nonagenarians?

Mon, 02 May 2016 14:07:33 +0100

An increasing number of nonagenarians present with severe aortic stenosis. Can they benefit from transcatheter aortic valve replacement? Journal of the American College of Cardiology (Source: Medscape Today Headlines)



CoreValve High-Risk Study at 3 Years: TAVR Advantage SustainedCoreValve High-Risk Study at 3 Years: TAVR Advantage Sustained

Fri, 15 Apr 2016 20:54:28 +0100

In this high-risk population with severe aortic stenosis, patients were less likely to die or have a stroke within 3 years if they had percutaneous rather than surgical valve replacement. Heartwire from Medscape (Source: Medscape Medical News Headlines)



Edwards Lifesciences hits all-time high on Sapien 3 study

Tue, 05 Apr 2016 13:15:49 +0100

Shares in Edwards Lifesciences (NYSE:EW) hit an all-time high yesterday after the company reported strong 1-year data for its Sapien 3 replacement heart valve over the weekend. Results from the Partner II trial from 1,077 intermediate-risk patients showed that the Sapien 3 beat surgical valve replacement across a variety of safety endpoints, Irvine, Calif.-based Edwards said at the American College of Cardiology’s annual meeting April 3. The combined all-cause death & disabling stroke rate was 8.4% for TAVR with Sapien 3 and 16.6% for the surgery arm, according to the study, which was also published in The Lancet. The Sapien 3 device won a nod from the FDA in June 2015 for high-risk patients. Expanding the indication to intermediate-risk patients would more than double the e...

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Edwards Lifesciences touts intermediate-risk data for Sapien devices | ACC 2016

Mon, 04 Apr 2016 11:54:23 +0100

Data from a large trial of the Sapien line of replacement heart valves made by Edwards Lifesciences (NYSE:EW) are slated to be used to back bids for expanded indications in intermediate-risk patients. Presented over the weekend at the American College of Cardiology’s annual meeting in Chicago, results from the Partner II trial involving the Sapien XT and Sapien 3 transcatheter aortic valve replacements compared the TAVR treatments with traditional open surgery in the intermediate-risk cohort (both of the Edwards valves are already approved in the U.S. for high-risk patients). Sapien XT non-inferior to surgery at 2 years For the 2nd-generation Sapien XT, approved by the FDA back in June 2014, the study followed 2,032 patients for 2 years. There were no significant difference betwe...



Rates of death and stroke equivalent for surgery and TAVR at two years

Sun, 03 Apr 2016 19:24:10 +0100

Intermediate-risk patients with severe aortic stenosis who receive minimally invasive transcatheter aortic valve replacement, known as TAVR, have similar rates of death and disabling strokes after two years compared with those undergoing standard open heart surgical replacement, according to a new study. Patients receiving TAVR also experienced shorter hospital stays and lower incidence of some major complications compared with those undergoing surgery. (Source: ScienceDaily Headlines)



Medtronic CoreValve® System Demonstrates Superior Survival to Surgery in Aortic Stenosis Patients with Lower STS Scores

Sun, 03 Apr 2016 04:40:00 +0100

The analysis of the sub-cohort compared 202 patients treated with the CoreValve System against 181 patients who received surgical aortic valve replacement (SAVR). The CoreValve TAVR patients demonstrated superior outcomes in all-cause mortality at two years compared to patients treated with surgical aortic valve replacement (15.0 percent vs. 26.3 percent; p=0.01). In addition, rates of combined all-cause mortality or major stroke were superior for TAVR with the CoreValve System (17.1 percent vs. 31.9 percent; p=0.0018). (Source: News from Angioplasty.Org)



Medtronic CoreValve ® System Demonstrates Superior Survival to Surgery in Aortic Stenosis Patients with Lower STS Scores

Sun, 03 Apr 2016 04:40:00 +0100

The analysis of the sub-cohort compared 202 patients treated with the CoreValve System against 181 patients who received surgical aortic valve replacement (SAVR). The CoreValve TAVR patients demonstrated superior outcomes in all-cause mortality at two years compared to patients treated with surgical aortic valve replacement (15.0 percent vs. 26.3 percent; p=0.01). In addition, rates of combined all-cause mortality or major stroke were superior for TAVR with the CoreValve System (17.1 percent vs. 31.9 percent; p=0.0018). (Source: News from Angioplasty.Org)



First Patients Enrolled in Medtronic Trial in Low-Risk Aortic Stenosis Patients

Fri, 01 Apr 2016 06:43:00 +0100

Medtronic plc (NYSE: MDT) today announced that the first patients were enrolled in the expanded indication trial for the CoreValve® Evolut® R System, the first and only next-generation recapturable, self-expanding transcatheter aortic valve replacement (TAVR) system commercially available in the United States. (Source: News from Angioplasty.Org)

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Post-TAVR Mortality Lower in Women

Wed, 30 Mar 2016 06:24:06 +0100

Women undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis have lower 1-year mortality than men, even though their 30-day rates of vascular complications and major bleeding are worse, according to a report published in Annals of Internal Medicine. (Source: Caring for the Ages)