The FDA said today that 1 of its advisory panels is due to convene for a hearing on the Absorb GT1 bioabsorbable stent developed by Abbott (NYSE:ABT). The federal safety watchdog’s Circulatory System Devices Panel is slated to meet March 15 for a vote on Abbott’s pre-market approval for the Absorb GT1 device, a coronary scaffold that’s […]
UPDATED Oct. 13, 2015 with expanded comments from Biotronik. Early data on a fully bioabsorbable metal stent, the Dreams 2G made by Biotronik, showed that the device performed better and was just as safe as older iterations of the technology, researchers said today at the annual Transcatheter Cardiovascular Therapies conference in San Francisco. The Dreams 2G […]
The Absorb bioabsorbable stent made by Abbott (NYSE:ABT) met its primary endpoint in a U.S. clinical trial that will be used to back a bid for FDA approval, researchers said today at the annual Transcatheter Cardiovascular Therapeutics conference in San Francisco. One-year data from the Absorb III trial of 2,008 patients showed that the Absorb […]
UPDATED Oct. 14, 2015, with comment from Boston Scientific’s Dr. Craig Thompson. The FDA approved Boston Scientific‘s (NYSE:BSX) Synergy drug-eluting stent for treating coronary artery disease, sending BSX shares up today and making BSX the 1st U.S. entrant on the next front in the stent wars. The Marlborough, Mass.-based company said the Synergy device’s bioabsorbable polymer is designed to dissolve completely after delivering […]
Arterial Remodeling Technologies said it won CE Mark approval in the European Union for its bioreabsorbable stent for treating coronary artery disease.