Major Adverse Cardiac Events in Abbott’s BVS Triggers FDA Investigation

By MedTech Intelligence Staff
March 20, 2017


• Categories: 04-Product Design & Development, 05-Quality/Regulatory, Combination Products

FDA issued a safety alert, notifying healthcare providers about an increased rate of major adverse cardiac events in patients who have the Abbott Vascular Absorb GT1 Bioresorbable Vascular Scaffold (BVS) versus patients treated with the company’s metallic XIENCE drug-eluting stent.

Implanted during an angioplasty, the BVS opens coronary arteries that have been blocked by plaque to increase blood flow to the heart. The device dissolves and is fully absorbed by the body after a period of time.

The agency reviewed two-year data from the BVS pivotal clinical study, the ABSORB III trial, which revealed an 11% rate of major adverse cardiac events in patients treated with the BVS at two years. This rate was compared with the 7.9% rate in patients treated with the Abbott Vascular’s XIENCE stent, which is FDA approved. At two years, there is also a 1.9% rate of thrombosis with the BVS, compared to 0.8% with the XIENCE stent. When the BVS is placed in small heart vessels, there was an observed higher adverse cardiac event rate.

FDA and Abbott Vascular are conducting more analyses to get to the bottom of the higher cardiac event and device thrombosis rates. The agency will monitor BVS performance in ongoing clinical studies and reports submitted to MedWatch (FDA’s safety and adverse event reporting program).

FDA has recommended against the use of BVS in small heart vessels and is advising healthcare providers to follow the optimal device implantation that is included in the BVS physician labeling.