Category: Cardiac ImplantsSyndicate content

UPDATE: 3rd FDA panel vote barely favors Boston Scientific's Watchman anti-stroke device

October 9, 2014 by Brad Perriello

An FDA advisory panel's unprecedented 3rd hearing over Boston Scientific's Watchman anti-stroke device barely favors the cardiac implant.

UPDATE: 3rd FDA panel vote barely favors Boston Scientific's Watchman anti-stroke device

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FDA panel offers mixed view on Boston Scientific Watchman device

October 8, 2014 by MassDevice

An FDA advisory panel gives a mixed view in its unprecedented 3rd review of Boston Scientific's Watchman anti-stroke device.

FDA panel offers mixed view on Boston Scientific Watchman device

FDA doubtful on new Watchman data from Boston Scientific

October 6, 2014 by Brad Perriello

The FDA expresses some doubts about new data from Boston Scientific on its Watchman anti-stroke device.

FDA doubtful on new Watchman data from Boston Scientific

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LoneStar Heart wins CE Mark for hydrogel heart implant

October 1, 2014 by Alex Soule

LoneStar Heart wins CE Mark approval in the European Union for its Algisyl-LVR hydrogel implant, a hydrogel implant designed to treat heart failure.

LoneStar Heart wins CE Mark for hydrogel heart implant

Laguna Hills, Calif.-based LoneStar Heart said it won CE Mark approval in the European Union for its Algisyl-LVR hydrogel implant for the treatment of advanced heart failure. 

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New data not so good for Boston Scientific's Watchman anti-stroke device

September 22, 2014 by Scott Wooldridge

New data presented last week at the annual Transcatheter Cardiovascular Therapies meeting showed Boston Scienfitic's Watchman anti-stoke device to be comparable to treatment with the anti-coagulant warfarin.

New data not so good for Boston Scientific's Watchman anti-stroke device

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St. Jude chases MRI-friendly labeling for its CRM devices

September 22, 2014 by Arezu Sarvestani

St. Jude Medical lands European approval to market its Tendril STS and IsoFlex Optim leads as safe for MRI scanning, adding that the company's just getting started on a larger MRI-safe campaign.

E.U. regulators dub St. Jude's Tendril STS, IsoFlex Optim leads safe with MRI

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