FDA Investigating Increased Cardiac Events In Patients Implanted With Abbott Vascular Scaffold

WASHINGTON, D.C. — The Food and Drug Administration has notified health care providers that there is an increased rate of major adverse cardiac events observed in patients who were implanted with Abbott Vascular Inc.’s Absorb GT1 Bioresorbable Vascular Scaffold (BVS) during heart surgery.

The BVS device is used to open coronary arteries blocked by scar tissue (plaque) in order to increase blood flow to the heart muscle. The BVS is implanted during an angioplasty procedure and gradually dissolves and is fully absorbed by the body over time.

In a March 18 letter, the agency explained that its review of …