FDA Panel Will Review Abbott Vascular's Absorb GT1 BVS and AngelMed's Guardian System

March 14, 2016—The Circulatory System Devices Panel of the Medical Devices Advisory Committee of the US Food and Drug Administration (FDA) will hold a public meeting on Tuesday, March 15, to discuss, make recommendations, and vote on information related to the premarket approval application for Abbott Vascular’s Absorb GT1 bioresorbable vascular scaffold (BVS) system. On Wednesday, March 16, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the AngelMed Guardian system sponsored by Angel Medical Systems, Inc.

As summarized in the FDA notice, the Absorb GT1 BVS system is a temporary scaffold that will fully resorb over time and is indicated for improving coronary luminal diameter in patients with ischemic heart disease caused by de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.

The AngelMed Guardian system is an implantable cardiac monitor intended to alert patients to ST-segment shifts indicating coronary ischemia. The AngelMed Guardian system is intended for use in patients with previous acute coronary syndrome events who are at risk for recurrent events by detecting ST-segment changes indicating cardiac ischemia.

The meeting will be held on March 15 and 16, 2016, from 8 AM to 6 PM at the Holiday Inn Gaithersburg in Gaithersburg, Maryland. Specific meeting information is available on the FDA website here. Background materials are available here.