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TAVR
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FDA Has Cleared The Way for Medtronic Corevalve
Apr 2, 2015CoreValve becomes first transcatheter heart valve approved for valve-in-valve procedures. Chris Newmarker Rendering of the CoreValve right after its transcatheter deployment. (Image courtesy of Medtronic) FDA has cleared the way for ...
Tags: FDA, Medicine, Medical Device
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Five Companies with The Most Stock Price Growth Over 2014
Dec 15, 2014Posted in Medical Device Business by Chris Newmarker on December 11, 2014 2014 has turned out to be a pretty decent year for the world’s 40 largest medical device companies: Only six of them have seen their stock prices decline, and ...
Tags: Medical Device, Health
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Next-Gen Heart Valve in U.S.A.
Jun 17, 2014Edwards' Sapien XT transcatheter aortic heart valve (Courtesy Edwards Lifesciences) Edwards Lifesciences Corp. (Irvine, CA) has announced both the FDA approval and the U.S. launch of its next-generation Sapien XT transcatheter aortic ...
Tags: Health, Medicine, heart valve
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Edwards Received Regulatory Approval to Sell Sapien 3 Transcatheter Aortic Heart Valve
Feb 11, 2014Edwards Lifesciences has received regulatory approval to sell its third-generation Sapien 3 transcatheter aortic heart valve in Europe. Edwards Lifescience's Sapien 3 could be used in a broader range of patients than earlier TAVR ...
Tags: Sapien, Medtronic', CoreValve
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Claret Medical Gets CE Mark Approval for Sentinel Cerebral Protection System
Feb 7, 2014US-based Claret Medical has obtained CE Mark approval for Sentinel Cerebral Protection System, the next generation product in its embolic protection portfolio. Claret Medical's Sentinel cerebral protection system (CPS) is designed for ...
Tags: CPS, TAVR, filter system, exemption
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The Company Believes The Ability to Prevent Such Leakage Is a Key Advantage for Product
Jan 9, 2014Direct Flow Medical (Santa Rosa, CA) has obtained the CE Mark for its 29-mm transcatheter aortic valve replacement device, which it hails as the first fully repositionable percutaneous heart valve. The ability to reposition the Direct Flow ...
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Creganna-Tactx Medical Will Showcase The Expertise of Its CaliforniaCenter of Excellence
Dec 20, 2013Creganna-Tactx Medical, a global Top 10 provider of medical device outsourcing solutions, will showcase the expertise of its CaliforniaCenter of Excellence for Emerging Therapies at the Transcatheter Cardiovascular Therapeutics (TCT) ...
Tags: medical device
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Approval for 25mm Portico Transcatheter Aortic Heart Valve Is Obtained by St. Jude Medical
Dec 16, 2013St. Jude Medical, a medical device company, has obtained CE Mark approval in Europe for its 25mm Portico transcatheter aortic heart valve implantation system. The Portico valve system offers a minimally invasive treatment option for ...
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The Largest Medical Device Companies Have Had a Good Run on The Stock Markets This Year
Dec 11, 2013The largest medical device companies have had a good run on the stock markets this year, with many clocking in double-digit percentage growth in stock prices over the past 12 months. There are always exceptions to the rule, however. Here ...
Tags: Medical Device, Medical Device Firms, Worst Performing Firms
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IDE Application for Sentinel Cerebral Protection System Is Submited by Claret Medical
Dec 4, 2013US-based Claret Medical has submitted an investigational device exemption (IDE) application to the US Food and Drug Administration (FDA) for a multicenter study of the company's Sentinel cerebral protection system (CPS) for embolic ...
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The FDA Granted The Direxion a 510(k) Clearance
Nov 26, 2013The Direxion Torqueable Microcatheter-a microcatheter for shrinking tumors or blocking aneurysms-has won FDA and CE Mark approval, Boston Scientific recently announced. The FDA granted the Direxion a 510(k) clearance because it retains ...
Tags: Boston Scientific Microcatheter, FDA Approval, Direxion a 510(k)
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The Sapien 3 Could Be Used in a Broader Range of Patients
Nov 21, 2013Posted in Cardiovascular by Qmed Staff on November 19, 2013 The Sapien 3 could be used in a broader range of patients than earlier TAVR products introduced internationally. Edwards Lifesciences (Irvine, CA) is in the news after The ...
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CE Mark Approval was obtained by Boston Scientific for Lotus Valve System
Oct 30, 2013US-based Boston Scientific has obtained CE Mark approval for its Lotus valve system, a transcatheter aortic valve replacement (TAVR) device designed to treat patients with severe aortic stenosis who are at high risk with surgical valve ...
Tags: Lotus Valve System, Health, Medicine
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Patient Enrollment Has Concluded in The First-in-Human Study of The Company's TAVI System
Oct 28, 2013Colibri Heart Valve announced that patient enrollment has concluded in the first-in-human study of the Company's transcatheter aortic valve implantation (TAVI) system in the Dominican Republic trial site. Analysis of the data from ...
Tags: Colibri Heart Valve, Tavi System
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CE Mark Approval for Cerebral Protection Device Is Obtained by Keystone Heart
Sep 10, 2013Keystone Heart, a developer and manufacturer of cerebral protection devices, has received CE Mark approval for its TriGuard cerebral protection device, designed to cover all three aortic cerebral branches to minimize the risk of cerebral ...
Tags: Keystone, Protection Device
