Category: Cardiac Implants
An FDA advisory panel's unprecedented 3rd hearing over Boston Scientific's Watchman anti-stroke device barely favors the cardiac implant.
An FDA advisory panel gives a mixed view in its unprecedented 3rd review of Boston Scientific's Watchman anti-stroke device.
The FDA expresses some doubts about new data from Boston Scientific on its Watchman anti-stroke device.
LoneStar Heart wins CE Mark approval in the European Union for its Algisyl-LVR hydrogel implant, a hydrogel implant designed to treat heart failure.
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.
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.
CE Mark approval expands the company's portfolio of cardiac rhythm devices with MRI compatibility.
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.