FDA Approves First Fully Absorbable Stent for Coronary Artery Disease — Physician’s First Watch

Medical News |
July 6, 2016

FDA Approves First Fully Absorbable Stent for Coronary Artery Disease

By Amy Orciari Herman

Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM

The first fully absorbable stent — the Absorb GT1 Bioresorbable Vascular Scaffold System — has been approved to treat coronary artery disease, the FDA announced on Tuesday.

The everolimus-eluting stent, which is absorbed in the body over roughly 3 years, is intended as an alternative to permanent metal stents. Once absorption is complete, only four small platinum markers remain embedded in the arterial walls to help physicians locate where the stent had been placed.

In a randomized trial among some 2000 patients, the rate of major adverse cardiac events at 1 year was "clinically comparable" with the Absorb stent (7.8%) and a drug-eluting metal stent (6.1%). Rates of stent thrombosis were 1.54% and 0.74%, respectively.

The Absorb stent should not be used in patients who are hypersensitive or allergic to everolimus or the materials used in the device, including poly(L-lactide), poly(D,L-lactide), and platinum.

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