Indian health regulators reportedly echoed the warning on using the Absorb bioresorbable stent made by Abbott (NYSE:ABT) in too-small coronary vessels.
Data unveiled in March at the annual conference of the American College of Cardiology showed that Absorb confers a higher risk of serious adverse events at two years compared with the company’s Xience drug-eluting stent, according to new data from a study that prompted the FDA to warn physicians on the risk. In response Abbott curtailed use of the device in Europe.
But the picture is clouded by new guidelines indicating the proper blood vessel size and implantation technique; some 19% of patients in the 2008-subject trial were implanted in arteries that were later deemed too small for the device. Excluding those patients, the difference between the two stents was not statistically significant, according to the study.
In a March 31 letter to physicians (posted online April 5 by a prominent cardiologist from Atlanta), Abbott said it would restrict use of the Absorb and Absorb GT1 devices to clinical registry studies as of May 31. The FDA has said it’s investigating the higher adverse event rate for Absorb, which it approved in July 2016 with the proviso that Abbott run a 5-year post-market study of the device.
The issue prompted the Drug Controller General of India to warn against using the Absorb devices in blood vessels smaller than 2.5mm, according to Live Mint. The stents can be used in larger vessels under controlled conditions, the website reported.
The DCGI also wants Abbott to run Phase IV trials there; a post-market surveillance study is already under way in the U.S., according to the report.
An Abbott spokesperson told the website via email that it’s in talks with India’s Central Drugs Standard Control Organization “on an ongoing basis” and that it has already submitted a plan for clinical follow-up of existing Absorb patients there.
“A CDSCO medical device alert of 7 April does not restrict the use of Absorb in India. We have submitted the updated [instructions for use] with respect to the change in the vessel diameter for DCGI’s approval,” the spokesperson wrote.
