Category: Cardiac ImplantsSyndicate content

Boston Scientific's lead-free S-ICD heads to Asia

April 8, 2014 by Arezu Sarvestani

Boston Scientific's novel lead-free implantable cardioverter defibrillator makes an introduction in the Asia Pacific region.

Boston Scientific's lead-free S-ICD tours Asia

Massachusetts medical device giant Boston Scientific (NYSE:BSX) is taking its S-ICD lead-free cardiac implant on tour, reaching new regions in Asia Pacific.

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ReliantHeart goes head-to-head with Thoratec to aim for U.S. LVAD market

April 7, 2014 by Arezu Sarvestani

ReliantHeart touts study data finding that its HeartAssist5 left ventricular assist device poses a lower risk of blood clots and damage compared with Thoratec's HeartMate II.

ReliantHeart aims for U.S. LVAD market, goes head-to-head with Thoratec

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Thoratec recall gets FDA's highest-risk label following injuries, deaths | MassDevice.com On Call

April 3, 2014 by Arezu Sarvestani

FDA regulators put their highest-risk Class I label on a recall of Thoratec's HeartMate II implantable heart pump after 5 patients injuries and 4 deaths were reportedly associated with a defect in controlling the implants.

MassDevice.com On Call

MASSDEVICE ON CALL — The FDA issued it's highest-risk Class I warning after Thoratec (NSDQ:THOR) recalled its HeartMate II implantable heart pumps over a controller issue that the FDA said was associated 4 patient deaths and 5 serious injuries.

Transcatheter Tech. touts no leakage at 6-months with Trinity TAVI

March 25, 2014 by Arezu Sarvestani

Transcatheter Technologies' touts zero instances of paravalvular leakage in 6-month pilot results for its Trinity transcatheter aortic valve implantation system.

TAVI: Transcatheter Tech. touts 6-month results for Trinity device

Transcatheter Technologies GmbH touted 6-month results from a pilot study of its Trinity transcatheter aortic valve implantation system, reporting no instances of valve leakage.

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Medtronic lands U.S., E.U. wins for miniature cardiac monitor

February 19, 2014 by Chris Walker

The Reveal LINQ insertable cardiac monitor is now available in the U.S. and European Union member countries after landing regulatory clearance from regulators in both regions.

Medtronic lands CE Mark, 510(k) clearance for miniature cardiac monitor

Medtronic (NYSE:MDT) landed both CE Mark approval in Europe and FDA 510(k) clearance in the U.S. for its Reveal LINQ insertable cardiac monitor.

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TAVI: Transcatheter Tech. closes valve prosthesis durability testing

February 7, 2014 by Chris Walker

Transcatheter Technologies completes durability testing on its Trinity 3rd-generation transcatheter aortic valve implantation system, after putting the device through an estimated 15 years' worth of cycles.

TAVI: Transcatheter Tech. finishes valve prosthesis durability testing

German device maker Transcatheter Technologies GmbH said it finished durability-testing Trinity transcatheter aortic valve implantation system.

The company expects Trinity to be "the world's 1st 'truly repositionable'" replacement aortic valve. The device was put through 600 million cycles, or around 15 years, of durability testing by an independent lab, which reported that the device far exceeded minimum standards, according to a press release.

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