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Mon, 05 Dec 2016 15:20:00 ESTLast 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)
Thu, 01 Dec 2016 13:45:00 ESTMedtronic 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.
Fri, 04 Nov 2016 08:00:00 +0200Dr. 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.)
Wed, 26 Oct 2016 23:00:00 +0200Medtronic 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.
Tue, 13 Sep 2016 22:10:00 PDTThe 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.
Fri, 02 Sep 2016 21:43:00 PDTMedtronic 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.
Fri, 02 Sep 2016 20:45:00 PDTIn 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.
Sun, 21 Aug 2016 20:53:00 PDTEdwards 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)."
Thu, 04 Aug 2016 19:58:00 PDTMedtronic 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.
Wed, 03 Aug 2016 16:32:00 PDTBoston 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.
Mon, 01 Aug 2016 11:23:00 PDTThis 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.
Sun, 24 Jul 2016 14:30:00 PDTIn 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.
Mon, 18 Jul 2016 20:00:00 PDTAbbott (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.
Wed, 13 Jul 2016 08:55:00 PDTMedtronic 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).
Tue, 05 Jul 2016 17:00:00 PDTAbbott 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.
Sun, 15 May 2016 23:55:00 +0200At 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.
Wed, 06 Apr 2016 16:43:00 PDTMedtronic 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).
Sun, 03 Apr 2016 11:07:00 PDTMedtronic 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.
Sat, 02 Apr 2016 21:40:00 PDTThe 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).
Fri, 01 Apr 2016 11:16:00 PDTPhilips Volcano Announces More Than 5,000 Coronary Artery Disease Patients Enrolled in iFR Outcomes Trials
Thu, 31 Mar 2016 23:43:00 PDTMedtronic 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.
Tue, 29 Mar 2016 22:04:00 PDTThe 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).
Mon, 28 Mar 2016 22:40:00 PDTThis 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.
Mon, 21 Mar 2016 23:09:00 PDTThis 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.
Tue, 15 Mar 2016 14:39:00 PDTAbbott (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.
Sat, 19 Mar 2016 15:01:00 PDTSt. 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.
Mon, 07 Mar 2016 11:28:00 PSTMedtronic 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.
Sun, 06 Mar 2016 16:49:00 PSTMajor 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.
Tue, 23 Feb 2016 16:37:00 PSTMedtronic (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.
Mon, 22 Feb 2016 20:56:00 PSTMedtronic 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.
Mon, 22 Feb 2016 19:53:00 PSTBoston 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.
Thu, 18 Feb 2016 14:17:00 PSTA 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.
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.
Wed, 10 Feb 2016 11:45:00 PSTProfessor 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.”
Tue, 09 Feb 2016 16:20:00 PSTSt. 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.
Fri, 05 Feb 2016 14:00:00 PSTThe 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.
Wed, 03 Feb 2016 15:02:00 PSTMedtronic 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.
Mon, 25 Jan 2016 19:20:00 PSTMedtronic, 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.
Sat, 23 Jan 2016 22:30:00 PSTNew 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.
Thu, 21 Jan 2016 21:00:00 PSTToday 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."
Mon, 11 Jan 2016 20:30:00 PSTMedtronic 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.
Thu, 17 Dec 2015 03:47:00 PSTThis 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.
Tue, 15 Dec 2015 22:00:00 PSTSvelte 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.