Subscribe: News from Angioplasty.Org
Added By: Feedage Forager Feedage Grade B rated
Language: English
angioplasty  collaboration tcross  fda  japan  medtronic  new  news  patients  posted collaboration  risk  study  tcross news  valve 
Rate this Feed
Rate this feedRate this feedRate this feedRate this feedRate this feed
Rate this feed 1 starRate this feed 2 starRate this feed 3 starRate this feed 4 starRate this feed 5 star

Comments (0)

Feed Details and Statistics Feed Statistics
Preview: News from Angioplasty.Org

Angioplasty.Org News

Breaking news about stents, angioplasty, the medical device industry, balloons, diagnostic imaging, interventional cardiology, stent thrombosis, restenosis from Angioplasty.Org

Last Build Date: Sun, 08 Jul 2012 17:00:00 PST

Copyright: copyright 2006-12 Venture Digital LLC

Interview with Yusuke Yoshikawa, MD

Fri, 10 Nov 2017 09:00:00 +0100

Dr. Yoshikawa discusses his study, just published in Circulation, titled "Validating Utility of DAPT Score in a Large Pooled Cohort from Three Japanese PCI Studies," and he comments on how the Japanese population differs from western patients in terms of bleeding and ischemic event rates. (posted in collaboration with TCROSS NEWS)

Complex CTO-PCI: The Japanese Approach

Tue, 31 Oct 2017 05:30:00 PDT

This 20 minute video shows a complex CTO case, in which an RCA obstruction, complicated by a sharp bend and tortuous anatomy, was revascularized using both the antegrade and retrograde approaches, facilitated by IVUS and biplane angiographic imaging. The operator is Dr. Etsuo Tsuchikane; the case was broadcast live during the Japanese CTO Club course in June 2017. (posted in collaboration with TCROSS NEWS)

Medtronic's Evolut PRO Now Available in Europe

Mon, 31 Jul 2017 13:47:00 PDT

Medtronic has announced that its latest transcatheter aortic valve, the CoreValve Evolut PRO, has received the CE mark and is now available for use in Europe. In a reversal of the usual order of device approvals, FDA approval pre-dated the CE Mark - the Evolut PRO was first given an FDA okay back in March. This new generation valve utilizes a biocompatible porcine outer wrap that increases surface contact and sealing to reduce paravavular leaks (PVL). Another major improvement over earlier iterations was the reduced necessity for permanent pacemaker implantation: only 10% in this cohort.

Clinical Trial to Study If 3-Months of DAPT is Safe After XIENCE Stent

Tue, 25 Jul 2017 17:59:00 PDT

The study, called XIENCE Short DAPT, will evaluate if 3 months of DAPT is non-inferior to the current standard of 12 months after implantation with a XIENCE stent for patients who are at high risk of bleeding. The study will enroll approximately 2,000 patients at 100 sites in the U.S. and Asia.

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

Mon, 10 Jul 2017 12:40:00 PDT

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.

Barriers to Achieving Optimal Door-to-Balloon Time in Japan: Interview with Dr. Shun Kohsaka

Fri, 30 Jun 2017 03:00:00 PDT

In this interview, co-author Dr.Shun Kohsaka of the Department of Cardiology at Keio University School of Medicine in Tokyo, Japan, discusses a study, recently published in the Japanese Circulation Society's Circulation Journal, demonstrating that door-ro-balloon time in half of STEMI cases in Japan is greater than 90 minutes.(Posted in collaboration with TCROSS NEWS.)

Prognostic Impact of Revascularization in Poor-Risk Patients with Critical Limb Ischemia: Interview with Dr. Osamu Iida

Sun, 18 Jun 2017 15:07:00 PDT

Dr. Iida was principal investigator for the PRIORITY registry, testing whether revascularization impacted survival at one-year for poor-risk-CLI patients. The study was published in the June 12 issue of JACC: Cardiovascular Interventions and looked at over 600 patients in 37 hospitals across Japan. (Posted in collaboration with TCROSS NEWS.)

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

Wed, 22 Mar 2017 10:50:00 PDT

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 Session, which showed high survival, low rates of stroke, minimal paravalvular leak (PVL) and excellent hemodynamics for the self-expanding valve.

First U.S. Case Done with Tryton's Side Branch Stent

Tue, 21 Mar 2017 23:53:00 PDT

Earlier this month, the FDA approved Tryton Medical's Side Branch Stent and today, at New York-Presbyterian Hospital/Columbia University Medical Center in New York, the first case was performed by two of the leading interventional cardiologists in the U.S., Dr. Martin Leon and Dr. Ajay Kirtane.

Medtronic's Micra Leadless Pacemaker Approved for Reimbursement in U.S.

Fri, 10 Mar 2017 18:28:00 PST

In a big leap forward for the use of leadless pacemakers, U.S. Centers for Medicare & Medicaid Services (CMS) today approved reimbursement coverage for Medtronic's Micra® Transcatheter Pacing System (TPS), the only FDA-approved leadless pacing system. A major advantage of leadless pacemakers is that they can be implanted via catheter, in a similar fashion to angioplasty, so no surgical incision or pocket is necessary.

Medtronic Launches Below-The-Knee Clinical Study in Europe for Treatment of PAD Using New Drug-Coated Balloon Technology

Thu, 09 Mar 2017 10:51:00 PST

This study will evaluate the IN.PACT 0.014 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter. This is an investigational device, which uses Medtronic's unique IN.PACT™ Admiral™ drug coating technology. The study will enroll approximately 60 patients at four sites in Europe. The primary endpoint is late lumen loss at nine months.

New Analysis of Reverse Trial Shows Medtronic CRT Devices Cost-Effective, While Helping Patients with Mild Heart Failure Live Longer

Sun, 05 Mar 2017 19:04:00 PDT

Medtronic plc (NYSE:MDT) today announced an economic analysis of five-year data showing that patients with mild heart failure who get cardiac resynchronization therapy (CRT) devices early in their treatment live longer and that implanting these devices is cost-effective, compared to optimal medical therapy.

Interview with Yukata Tanaka, MD, PhD

Tue, 21 Feb 2017 19:00:00 PST

Dr. Yutaka Tanaka discusses his group's study on transradial coronary interventions for complex chronic total occlusion, just published in JACC: Cardiovascular Interventions. The patient population for this single-center study comprised almost 600 patients and looked at whether the transradial approach was feasible for complex chronic total occlusions. (Posted in collaboration with TCROSS NEWS.)

Medtronic Goes Radial

Mon, 13 Feb 2017 16:23:00 PST

Medtronic is now offering a full portfolio of transradial tools: a line of catheters, a TRA access kit with introducer sheath, and its TRAcelet™ compression device for simplifying patent hemostasis post-procedure. Although the company previously has marketed a select number of items designed for the transradial approach (TRA), today's announcement marks the first full-transradial offering by a major stent manufacturer in the U.S.

First Drug-Coated Balloon (DCB) Study Results in Japan Demonstrate Consistent Clinical Outcomes with Other Medtronic DCB Studies

Thu, 09 Feb 2017 10:07:00 PST

The IN.PACT SFA Japan Trial enrolled 100 patients at 11 sites in Japan who were randomized to treatment with either the DCB (n=68) or plain balloon angioplasty (percutaneous transluminal angioplasty, or PTA) (n=32). Per protocol, primary patency rates were assessed at 12 months of follow-up and demonstrated: 89.2 percent for the DCB group and 48.4 percent for the PTA group (p<0.001).

Medtronic CardioInsight Mapping Solution Cleared by FDA

Tue, 07 Feb 2017 18:31:00 PST

Cardiac mapping - typically accomplished by inserting a catheter into the heart via an artery or vein - allows physicians to locate the origin of a patient's irregular heart rhythms (arrhythmias). In contrast, the CardioInsight system is the first commercially released, noninvasive, cardiac electrical mapping system in the world, eliminating the invasive steps of this clinical procedure.

Medtronic Announces CE Mark for New Lower Profile HawkOne 6F Directional Atherectomy System

Tue, 24 Jan 2017 15:34:00 EST

Medtronic plc (NYSE: MDT) today announced CE (Conformité Européene) Mark approval for the HawkOne™ directional atherectomy system in a lower profile size for treating patients with peripheral artery disease (PAD).

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 18:59:00 EST

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.

Abbott's Acquisition of St. Jude to Close This Week

Mon, 02 Jan 2017 19:20:00 EST

As of Wednesday, January 4, St. Jude Medical will no longer exist as a company; instead it will become part of Abbott, according to the press release below. This $25 billion deal is one of the largest recent mergers of medical device companies since Medtronic's 2015 acquisition of Covidien.

Japan Announces Regulatory Process and Post Marketing Surveillance Policy for Abbott's Bioabsorbable Vascular Scaffolding

Mon, 05 Dec 2016 15:20:00 EST

Last week Dr. Takashi Ouchi, a reviewer for the Office of Medical Devices III of the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), announced the regulatory process and post marketing surveillance (PMS) policy that will be in effect for the Abbott Absorb bioabsorbable vascular scaffold (BVS). (This article was provided to Angioplasty.Org by its Japanese partner, TCROSS NEWS)

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

Thu, 01 Dec 2016 13:45:00 EST

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.

Interview with Hiroki Shiomi, MD, PhD

Fri, 04 Nov 2016 08:00:00 +0200

Dr. Hiroki Shiomi discusses the ReACT study from Japan which he presented at TCT2016. This study randomized 700 patients to either routine angiographic follow-up post-PCI or to clinical follow-up only to see if there was any additional benefit to angiography which is practiced in 80% of patients in Japan. (Posted in collaboration with TCROSS NEWS.)

Medtronic Announces FDA Approval of New Recaptureable TAVR System Available for Severe Aortic Stenosis Patients with Large Anatomies

Wed, 26 Oct 2016 23:00:00 +0200

Medtronic plc (NYSE:MDT) today announced FDA approval and U.S. launch of the CoreValve™ Evolut™ R 34mm valve-the largest sized transcatheter aortic valve replacement (TAVR) system available in the U.S. The new Evolut R 34mm valve is approved for severe aortic stenosis patients who are at 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 25-30 percent of the eligible global TAVR patient population.

Medtronic's IN.PACT Drug-Coated Balloon: First to Gain FDA OK for Treatment of In-Stent Restenosis in the Peripheral Vessels

Tue, 13 Sep 2016 22:10:00 PDT

The FDA has approved the first drug-coated balloon in the United States for the treatment of in-stent restenosis (ISR) in the peripheral arteries: Medtronic's IN.PACT Admiral drug-coated balloon (DCB). One-year outcomes from the IN.PACT Global ISR Imaging Cohort were presented at last year's VIVA meeting: the primary patency rate was 88.7% the clinically-driven target revascularization (CD-TLR) rate was 7.3%, outcomes that begin to approach what has been seen in the coronaries.

Medtronic Technologies Improve Delivery of Cardiac Resynchronization Therapy

Fri, 02 Sep 2016 21:43:00 PDT

Medtronic plc (NYSE:MDT) today announced results from the Cardiac Resynchronization Therapy Efficacy Enhancement (CRTee) study. The study showed that the Medtronic-exclusive device-based EffectivCRT™ during AF algorithm improves therapy delivery in heart failure patients with atrial fibrillation (AF). The results were presented at the 2016 European Society of Cardiology (ESC) Congress in Rome.

New Long-Term Data Reinforce Safety Benefits of the World's Smallest Pacemaker

Fri, 02 Sep 2016 20:45:00 PDT

In the largest and longest clinical evaluation of leadless pacing patients to date, Medtronic plc (NYSE: MDT) today announced new long-term results from the Medtronic Micra® Transcatheter Pacing System (TPS) Global Clinical Trial in a clinical trial update late-breaking session at the 2016 European Society of Cardiology (ESC) Congress in Rome.

SAPIEN3 Transcatheter Aortic Valve Gets FDA Approval for Patients at Intermediate Risk for Surgery

Sun, 21 Aug 2016 20:53:00 PDT

Edwards has received an important expansion of indications for its Transcatheter Aortic Valve (TAVR), the SAPIEN3. Initially approved only for patients at high risk for open surgery, the FDA has now approved use of the SAPIEN3 for patients at "intermediate risk" for surgery, specifically those who, according to the FDA announcement "are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality > 3% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator)."

Can Drug-Coated Balloon plus Atherectomy Be a Successful Treatment for Calcified FemPop PAD?

Thu, 04 Aug 2016 19:58:00 PDT

Medtronic and VIVA Physicians have launched the REALITY study: to see if directional atherectomy, combined with a drug-coated balloon, is a successful therapeutic option for these difficult cases of calcified and symptomatic femoropopliteal peripheral artery disease (PAD). The study will enroll around 150 patients, who will be treated with Medtronic's HawkOne or TurboHawk atherectomy devices, and then the IN.PACT Admiral paclitaxel drug-coated balloon. Patients will be followed for two years.

Boston Scientific Issues Urgent Lotus Valve Recall

Wed, 03 Aug 2016 16:32:00 PDT

Boston Scientific has issued a global recall of all Lotus™ transcatheter aortic valves that were manufactured before March 2016. The problem with the Lotus Valve was not with the valve itself, but with a component of the delivery system. The problem was fixed via a manufacturing change in March, but the previously manufactured product had not been recalled, and is now implicated in three patient deaths due to catastrophic vessel trauma.

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

Mon, 01 Aug 2016 11:23:00 PDT

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.

Will Abbott's Absorb Bioresorbable Vascular Scaffold Revolutionize Treatment of Coronary Artery Disease?

Sun, 24 Jul 2016 14:30:00 PDT

In Part One of this feature, we reported on the various positives and negatives of the BVS, as presented to the FDA panel that recommended approval. In this, Part Two, we discuss the Absorb's potential impact in the United States with three leading interventional cardiologists, Drs. Ajay Kirtane, James Blankenship, and Daniel Simon.

Health Canada Approves Abbott's Absorb™ Bioresorbable Stent, the First Fully Dissolving Heart Stent

Mon, 18 Jul 2016 20:00:00 PDT

Abbott (NYSE: ABT) announced today that Health Canada has approved the company's Absorb bioresorbable heart stent, making the first-of-its-kind medical device commercially available to treat people in Canada with coronary artery disease. Abbott's Absorb heart stent is a first-of-its-kind medical device that is made of a naturally dissolving material. After opening up a clogged heart artery, Absorb completely dissolves in about three years.

Medtronic Receives FDA Approval for IN.PACT Admiral DCB 150 mm Lengths

Wed, 13 Jul 2016 08:55:00 PDT

Medtronic plc (NYSE: MDT) has received U.S. Food and Drug Administration (FDA) approval for the IN.PACT™ Admiral™ drug-coated balloon (DCB) in longer, 150 mm lengths. The new 150 mm length balloon, available in four, five, and six mm diameters, will provide greater treatment options for long lesions in patients with peripheral artery disease (PAD).

FDA Approves Abbott's Absorb™ Bioresorbable Stent, The Only Fully Dissolving Heart Stent

Tue, 05 Jul 2016 17:00:00 PDT

Abbott announced today that the U.S. Food and Drug Administration has approved the company's Absorb bioresorbable heart stent, making the first-of-its-kind medical device commercially available to treat people with coronary artery disease in the United States.

Philips Volcano Activities at EuroPCR

Sun, 15 May 2016 23:55:00 +0200

At this year's EuroPCR meeting in Paris, Philips will be celebrating the one-year anniversary of its partnership (read "acquisition") of Volcano Corporation, making it the only cath lab imaging manufacturer able to offer intravascular options such as intravascular ultrasound (IVUS), fractional flow reserve (FFR) and its own proprietary non-adenosine functional measurement technology, iFR.

FDA OK to Medtronic's Micra: World's Smallest and 1st Transcatheter Pacemaker Approved in U.S.

Wed, 06 Apr 2016 16:43:00 PDT

Medtronic plc (NYSE:MDT) today announced it has received U.S. Food and Drug Administration (FDA) approval of the world's smallest pacemaker, the Medtronic Micra Transcatheter Pacing System (TPS). The Micra TPS is the first FDA-approved product with miniaturized pacing technology. It is cosmetically invisible and small enough to be delivered through a catheter and implanted directly into the heart -providing a safe alternative to conventional pacemakers without the complications associated with cardiac wires (leads).

Medtronic Announces Early Data and Completes Enrollment in CE Mark Cohort in Drug-Filled Stent Trial

Sun, 03 Apr 2016 11:07:00 PDT

Medtronic plc (NYSE: MDT) announced new clinical data today from one of the endpoints in the RevElution Trial for its novel, next-generation Drug-Filled Stent (DFS). These new data showed rapid vessel healing without inflammation in Optical Coherence Tomography (OCT) data of the complete one-month follow-up patient cohort.

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

Sat, 02 Apr 2016 21:40:00 PDT

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).

Philips Volcano Announces More Than 5,000 Coronary Artery Disease Patients Enrolled in iFR Outcomes Trials

Fri, 01 Apr 2016 11:16:00 PDT

Philips Volcano Announces More Than 5,000 Coronary Artery Disease Patients Enrolled in iFR Outcomes Trials

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

Thu, 31 Mar 2016 23:43:00 PDT

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.

Societies Update Guidelines for Dual Antiplatelet Therapy

Tue, 29 Mar 2016 22:04:00 PDT

The American College of Cardiology and the American Heart Association today released updated guidelines for dual antiplatelet therapy in patients with coronary artery disease. In general, duration of dual antiplatelet therapy recommendations in the document consist of a Class I recommendation of “should be given” for a minimum time period of time (usually six to 12 months).

Opsens Receives FDA 510(K) Clearance for the OptoWire II

Mon, 28 Mar 2016 22:40:00 PDT

This approval allows Opsens to market the OptoWire II in the world’s largest market. The OptoWire II is a new design comprising a hydrophilic coating that further improves the performances of the guidewire in different scenarios, such as in highly calcified and tortuous vessels.

FDA Panel Recommends Abbott's Absorb Bioresorbable Vascular Scaffold for Approval

Mon, 21 Mar 2016 23:09:00 PDT

This is the first installment of a two part feature regarding current thinking about the Bioresorbable Vascular Scaffold. Part One discusses the history and some general background issues surrounding the device; Part Two (to be posted later this week) consists of comments from leading interventional cardiologists about the current and future implications, predictions, critiques, and recommendations for the utilization of BVS.

Abbott's Absorb™, the First Fully Dissolving Heart Stent, Earns Positive Review by FDA Advisory Committee

Tue, 15 Mar 2016 14:39:00 PDT

Abbott (NYSE: ABT) announced today that an independent panel of experts convened by the U.S. Food and Drug Administration (FDA) voted 9 to 0, with one abstention, that the benefits of Abbott's Absorb fully bioresorbable drug eluting coronary stent outweigh the risks.

St. Jude Medical Secures CE Mark Approval of MRI Compatibility for the Nanostim Leadless Pacemaker

Sat, 19 Mar 2016 15:01:00 PDT

St. Jude Medical, Inc. (NYSE:STJ) today announced CE Mark approval for magnetic resonance (MR) conditional labeling for 1.5 T scans for the company’s Nanostim™ leadless pacemaker. With the approval, throughout Europe both existing patients implanted with a Nanostim leadless pacemaker and new patients receiving a Nanostim leadless pacemaker in the future can safely undergo full-body MRI diagnostic scans.

Medtronic Begins CoreValve™ Evolut™ R "Real World" TAVR Study

Mon, 07 Mar 2016 11:28:00 PST

Medtronic plc (NYSE: MDT) has announced the start of a new "real world" study of its CoreValve Evolut R transcatheter aortic valve. The first patients were enrolled at University Hospital in Bonn, Germany. The FORWARD study will enroll up to 1,000 patients at 60 centers worldwide.

Pete Nicholas to Retire as Boston Scientific Board Chairman

Sun, 06 Mar 2016 16:49:00 PST

Major medical device company Boston Scientific (NYSE:BSX) has announced that Pete Nicholas, its long-serving Chairman of the Board of Directors and co-founder, will formally retire from the Board in May. Founded almost four decades ago by Nicholas and John Abele, who met at their sons' soccer game in Massachusetts, Boston Scientific became one of the leading manufacturers of medical devices used in the interventional treatment of heart disease, stroke and more.

FDA Approves New CoreValve Low-Risk TAVR Study

Tue, 23 Feb 2016 16:37:00 PST

Medtronic (NYSE: MDT) has announced FDA approval for a new study of transcatheter aortic valve replacement (TAVR). But this trial is different; this trial will be in patients at low-risk for the standard surgical procedure (SAVR). The device will be Medtronic's latest TAVR iteration, the CoreValve® Evolut® R, approved last June by the FDA, and will include 1,200 patients at up to 80 sites.

Medtronic Receives CE Mark for Full Line of Cardiac Resynchronization Therapy-Defibrillators Compatible with MRI Scans

Mon, 22 Feb 2016 20:56:00 PST

Medtronic plc (NYSE:MDT) today announced that it has received CE (Conformité Européenne) Mark for the first and only cardiac resynchronization therapy defibrillators (CRT-Ds) approved for 3 Tesla (T) magnetic resonance imaging (MRI) scans, providing CRT-D patients with access to the most advanced imaging diagnostic procedures available.

CE Mark for Boston Scientific's Eluvia Peripheral Stent

Mon, 22 Feb 2016 19:53:00 PST

Boston Scientific (NYSE: BSX) announced this morning that its Eluvia™ Drug-Eluting Vascular Stent has received the CE Mark for use in treating peripheral artery disease in the superficial femoral and proximal popliteal arteries. The company states that the Eluvia is the first polymer-based DES approved in Europe for use in the peripheral arteries.

Meta-Analysis Shows Medtronic's Solitaire™ Stent Retriever Device Improves Functional Outcomes for Acute Ischemic Stroke Patients; Reduced Mortality in Patients 80+

Thu, 18 Feb 2016 14:17:00 PST

A meta-analysis published online today in Stroke and presented at the International Stroke Conference (ISC) in Los Angeles, Calif., found that the addition of Medtronic plc's (NYSE: MDT) Solitaire™ stent retriever to current pharmaceutical treatment (IV-tPA) significantly improves functional outcomes in patients suffering stroke. The analysis also showed a significant reduction (20% vs. 40%, adjusted OR 3.7(1.3-10.6), p=0.01) in mortality for patients over the age of 80.

"Alarming" Increase in Heart Attacks Among Young Adults in India Due to Smoking and Lifestyle

Wed, 10 Feb 2016 17:44:00 PST

"Stop Smoking!" is the heightened warning for young adults in India, based on a study presented today at the 67th Annual Conference of the Cardiological Society of India. The study looked at 310 patients who presented with acute coronary syndrome (ACS) during a two-year period to the Casualty (Emergency) Department of Sir Sunderlal Hospital. The frightening statistic is that the average age of these patients was 30 years old. The patients were almost all male, 90%, with the youngest ACS patient only 15 years of age.

New Real-World Comparison Showing Similar Efficacy Between the Lutonix® and In.Pact™ Drug-Coated Balloons Featured at LINC 2016

Wed, 10 Feb 2016 11:45:00 PST

Professor Dierk Scheinert, M.D., Head of the Department of Interventional Angiology at the University of Leipzig in Germany, commented, “These single-center results, like others before, show that real-world patients are benefiting from drug-coated balloon technology; and furthermore, the study indicates that there is no significant difference in the need for revascularization following treatment with either of these two DCBs.”

St. Jude Launches Mobile OCT/FFR/Angio System for Cath Labs in Europe and Japan

Tue, 09 Feb 2016 16:20:00 PST

St. Jude Medical (NYSE:STJ) recently announced that it has launched a mobile version of its OPTIS™ Integrated System in Japan and Europe. Like its built-in console cousin, the new system, dubbed OPTIS Mobile System, brings together optical coherence tomography (OCT), fractional flow reserve (FFR) and standard angiography.

FDA Nod to Medtronic MR-Conditional CRT-Defibrillators

Fri, 05 Feb 2016 14:00:00 PST

The U.S. FDA has cleared the first and only MR-conditional cardiac resynchronization therapy defibrillators (CRT-Ds) for the treatment of heart failure: Medtronic's Amplia and Compia MRI™ Quad CRT-D SureScan® systems. This approval expands Medtronic’s portfolio to include a complete line of MR-conditional cardiac devices, including MR-conditional pacemakers, implantable cardiac defibrillators (ICDs), insertable cardiac monitors (ICMs) and now CRT-Ds.

FDA OKs Expanded Patient Population for CoreValve

Wed, 03 Feb 2016 15:02:00 PST

Medtronic plc (NYSE:MDT) announced today that the FDA has revised the IFU (Instructions for Use) labeling for the CoreValve System to now include patients with end-stage renal disease and low flow, low gradient aortic stenosis. Previously, physicians were cautioned in the IFU against treating these patient populations with TAVR because of their severe comorbidities. The FDA's decision was based on positive data from the CoreValve U.S. Expanded Use Study.

Patient Education About Aortic Stenosis? There's an App for That!

Mon, 25 Jan 2016 19:20:00 PST

Medtronic, manufacturer of both surgical and percutaneous valves, has developed an easy-to-use iPad app, explaining the disease, its treatment options and, importantly, what happens after discharge from the hospital, when the level of care is reduced and additional support becomes very important. Dubbed the "Aortic Stenosis Patient Journey iPad App," nursing staff, as well as patients and their family, can download this tool from the iTunes store for free.

Svelte Launches Its Slender IDS Stent-on-a-Wire System in Europe

Sat, 23 Jan 2016 22:30:00 PST

New Jersey-based Svelte Medical Systems, Inc. announced this week the launch of its novel SLENDER IDS stent-on-a-wire in Europe and other countries that accept the CE Mark. Svelte is planning to submit a PMA application to the US FDA this year. The SLENDER IDS gained the CE Mark last month and the company is now making the product available to select accounts in Europe that specialize in the transradial approach.

Clinical Trial of Novel Infusion Device for Below the Knee Angioplasty Begins in Germany

Thu, 21 Jan 2016 21:00:00 PST

Today Mercator MedSystems announced the start of a clinical trial for its Bullfrog® Micro-Infusion Device which will treat the blockage post-angioplasty (or atherectomy) with a dose of dexamethasone, an anti-inflammatory steroid, in the hopes of preventing the build-up of scar tissue which leads to restenosis of the vessel. Prof. Dr. Dierk Scheinert commented, "We are very excited with the start of this important clinical trial. There remains a real need for enhancements in therapy for treating patients with critical limb ischemia (CLI). We aim to show with this trial that the therapy can improve the outcomes in this desperate condition."

Medtronic IN.PACT Admiral DEB Receives CE Mark for Treatment of AV Access In Patients with End-Stage Renal Disease

Mon, 11 Jan 2016 20:30:00 PST

Medtronic plc (NYSE:MDT) today announced that the IN.PACT® Admiral® drug eluting balloon has received CE (Conformité Européene) Mark for arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease.

Medtronic to Build New Plant in Ireland for Manufacturing the IN.PACT Drug-Coated Balloon

Thu, 17 Dec 2015 03:47:00 PST

This week, Medtronic announced that it was investing $14 million to build a new 20,000 sq. ft. plant in Galway, Ireland, specifically to manufacture the IN.PACT drug-coated balloon. This project is a direct outgrowth of Medtronic's merger with Ireland-based Covidien, a company which had its own DCB, the Stellarex, which was sold off to Spectranetics as part of the requirements for the merger.

Svelte's Stent-on-a-Wire Gains CE Mark

Tue, 15 Dec 2015 22:00:00 PST

Svelte Medical Inc., a relatively small device manufacturer based in New Jersey today achieved a milestone: the CE Mark approval that will allow the company to commercialize its novel stent-on-a-wire in Europe and other countries that accept the CE Mark. Svelte hopes to submit a PMA application to the FDA in 2016. The approval was based mainly on the results of the DIRECT II study of 189 patients which showed no stent thrombosis at four years and efficacy, measured by target vessel failure and in-stent late loss, at least as good as the standard drug-eluting stents currently on the market.