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FDA Has Cleared The Way for Medtronic Corevalve

Apr 2, 2015

CoreValve 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

Four Companies Turned Things Around After Facing Rough Starts in Early 2014

Sep 23, 2014

This year is proving to be a pretty good year for many medtech companies. The majority of the largest 40 have seen their stock prices rise by double-digit percentages in 2014, according to a Qmed analysis. Meanwhile, only eight have seen ...

Tags: Medtech Companies, Medical device

Next-Gen Heart Valve in U.S.A.

Jun 17, 2014

Edwards' 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

The European Interventional Cardiology Report Covers Markets for Tissue Heart Valves

May 19, 2014

Two new reports from iData Research cover the US market for vascular access devices and the European markets for cardiac surgery and heart valve devices. The European interventional cardiology report covers markets for tissue heart ...

Tags: Medtech Markets, US market

FDA Has Given Its Approval to Iteration of Sorin Mitroflow Aortic Pericardial Heart Valve.

Apr 28, 2014

Sorin's just-approved Mitroflow valve (Courtesy Sorin Group) Italy's Sorin Group has announced that FDA has given its approval to the latest iteration of the company's Sorin Mitroflow aortic pericardial heart valve. This newest version ...

Tags: Health, Medicine

Medtronic's CoreValve Transcatheter Aortic Valve Replacement Device.

Apr 15, 2014

Medtronic's CoreValve transcatheter aortic valve replacement device. (Courtesy Medtronic) Almost before the judge's signature was dry on Friday's federal district court preliminary injunction in favor of Edwards Lifesciences Corp. ...

Tags: Health, Medicine

Baby Hearts Need Rhythm to Develop Correctly

Feb 27, 2014

To develop correctly, baby hearts need rhythm...even before they have blood to pump. "We have discovered that mechanical forces are important when making baby hearts," said Mary Kathryn Sewell-Loftin, a Vanderbilt graduate student working ...

Tags: Baby Heart, Rhythm, Roadmap, SysCODE

Edwards Received Regulatory Approval to Sell Sapien 3 Transcatheter Aortic Heart Valve

Feb 11, 2014

Edwards 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

Transcatheter Technologies Complets AWT of The Company's Trinit Valve Prosthesis

Feb 7, 2014

Transcatheter Technologies has announced that an independent laboratory has completed ‘advanced wear testing’ (AWT) of the company’s Trinity valve prosthesis, far exceeding minimum testing standards. Indeed, AWT of the ...

Tags: AWT, TAVI, PVL, Trinity valve

Medtronic Willfully Infringed on an Edwards Lifesciences' Patent

Jan 16, 2014

Medtronic willfully infringed on an Edwards Lifesciences’ patent with its CoreValve transcatheter heart valve, and owes Edwards nearly $394 million in damages and patent royalties, a federal jury in Delaware found Wednesday. Edwards ...

Tags: Medtronic, CoreValve, transcatheter heart valve, Edwards

The Company Believes The Ability to Prevent Such Leakage Is a Key Advantage for Product

Jan 9, 2014

Direct 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 ...

Tags: Health, Medicine

Carmat Announced That Its Artificial Heart Was Successfully Implanted Into a Person

Dec 25, 2013

Carmat recently announced that its artificial heart was successfully implanted into a person on Dec. 18 during a procedure performed by the Georges Pompidou European Hospital team in Paris. The French company two days later was reporting ...

Tags: artificial heart, health

Kcentra Helps Restore Blood Coagulation

Dec 18, 2013

CSL Behring has announced that Kcentra (prothrombin complex concentrate [human]) has received the US Food and Drug Administration (FDA) approval for an expanded indication -- urgent reversal of acquired coagulation factor deficiency induced ...

Tags: CSL Behring, Medicine

Approval for 25mm Portico Transcatheter Aortic Heart Valve Is Obtained by St. Jude Medical

Dec 16, 2013

St. 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 ...

Tags: St.Jude Medical, Aortic Heart Valve

The Largest Medical Device Companies Have Had a Good Run on The Stock Markets This Year

Dec 11, 2013

The 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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