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 […]
Bioabsorbable Stents
TCT 2015: First-in-human results for Biotronik’s Dreams 2G absorbable stent
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 […]
TCT 2015: Abbott’s Absorb meets endpoint in U.S. pivotal trial
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 […]
FDA approves Boston Scientific’s Synergy absorbable stent
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 […]
Abbott wins CE Mark for next-gen Absorb device
Arterial Remodeling wins CE Mark for bioreabsorbable stent
Arterial Remodeling Technologies said it won CE Mark approval in the European Union for its bioreabsorbable stent for treating coronary artery disease.
Reva Medical extends Fantom stent trial to Europe
Micell launches all-comers trial for absorbable-polymer stent
Reva Medical raises $25m for Fantom bioabsorbable stent
Boston Scientific: Our new Synergy stent is as good as Promus
Elixir Medical touts E.U. win for disappearing DESolve 100 stent
California stent-maker Elixir Medical won approval from European regulators for its next-generation DESolve 100 fully resorbable coronary scaffold.
