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 designed to elute the drug everolimus before dissolving entirely over a period of months.
The proposed indication for Absorb GT1 is improving coronary luminal diameter in patients with ischemic heart disease due to de novo lesions of up to 24mm in blood vessel diameters of 2.5mm to 3.75mm, the FDA said.
The Absorb GT1 landed CE Mark approval in the European Union in May 2015. The Absorb stent met the primary endpoint in a Phase III pivotal trial, researchers announced last October at the annual Transcatheter Cardiovascular Therapeutics conference.
“Abbott looks forward to providing the panel with a robust view of the clinical trial results for Absorb and patient experiences among the more than 125,000 patients who have been treated with this naturally dissolving device, in more than 100 countries,” an Abbott spokesman told MassDevice.com via email.
Abbott is on track for Absorb approvals in China and Japan.
The FDA’s circulatory devices panel is also due March 16 to consider the pre-market approval bid by Angel Medical Systems’s AngelMed Guardian implantable cardiac monitor.