Yesterday, the U.S. Food and Drug Administration’s (FDAs) Circulatory Systems Device Panel convened to consider whether the FDA should approve Abbott Vascular’s Absorb GT1 Bioresorbable Vascular Scaffold (BVS).
The Absorb GT1 BVS System is a temporary scaffold that will fully resorb over time and is intended for improving coronary luminal diameter in patients with de novo native coronary artery lesions. If the BVS is approved by the FDA, Abbott has promised the FDA to conduct a post-approval registry of 2,000 to 3,000 patients with five-year follow-up.
During the Advisory Panel discussion, I had the privilege of representing the Society and providing testimony concluding that the FDA should approve the BVS so that this new technology is available for US patients. SCAI was the only society to provide comments to the Advisory Panel, the only society fighting to provide greater access to this new therapy for the interventional cardiovascular community and our patients.
The panel voted 9-1 that the BVS is safe, 10-0 that it is effective and 9-0 with one abstention that its benefits outweigh its risks. The FDA will consider the panel’s recommendation and likely make a final decision regarding the Absorb BVS at some point in 2016. Some panel members characterized the BVS as a paradigm shift, heralding a new era in interventional cardiology. However, Abbott Vascular leaders and panel members agreed that if the BVS is approved, physician education will be required to ensure it is deployed safely.
Just as SCAI is leading the interventional community through its advocacy efforts, we also intend to do the same through our education efforts. SCAI has developed a continuing medical education (CME)-certified Grand Rounds’ curriculum covering new interventional innovations -- including fully bio-absorbable stent scaffoldings --which will be offered at 40 hospital sites throughout the United States. To extend the reach of the curriculum, an online expert roundtable discussion will also be offered through Medscape Education. The online activity will concentrate clinical discussion points and case scenarios into a concise, understandable and easy-to-access CME activity, providing participants with important highlights and best practices from renowned experts. Additionally, SCAI 2016 will feature content focusing on new stent technologies, including BVS.
I encourage all SCAI members to actively participate in one, or all, of these educational initiatives.
James C. Blankenship, MD, MHCM, MSCAI
SCAI President, 2015-16