FDA
7th April 2016

FDA Device Panel Backs Breakthrough Bioresorbable Stent

On March 15th and 16th, the Circulatory System Devices Panel of the Medical Devices Advisory Committee voted in support of the approval of the Absorb GT1 bioresorbable vascular scaffold (BVS) system (Abbott Vascular) to improve coronary luminal diameter in patients with ischemic heart disease due to two or more de novo coronary artery lesions (length < 24 mm).

FDA Device Panel Backs Breakthrough Bioresorbable Stent

On March 15th and 16th, the Circulatory System Devices Panel of the Medical Devices Advisory Committee voted in support of the approval of the Absorb GT1 bioresorbable vascular scaffold (BVS) system (Abbott Vascular) to improve coronary luminal diameter in patients with ischemic heart disease due to two or more de novo coronary artery lesions (length < 24 mm).

Approval of this system would make Absorb the first drug-eluting coronary stent with a fully resorbable vascular scaffold in the US. While Absorb has a standard delivery system, its polymeric scaffold that absorbs within about 36 months distinguishes it from other drug-eluting stents.

Based on data from the ABSORB III trial, the panel weighed in on the product’s safety, efficacy and risk/benefit profile. Overall, the panel voted in favor of Absorb’s safety (9 yes, 1 no), efficacy (10 yes, 0 no) and risk/benefit profile (9 yes, 1 abstain).

Panel chair, Dr. Richard Page (University of Wisconsin-Madison) stated, “The holy grail is the idea of putting in a stent that stays open, elutes a drug to keep it open, and then disappears. People have been talking about this sort of thing for the past two decades as far as I’m aware, and I consider the technology potentially transformative.”

However, some panel members expressed concerns regarding the study’s 4.5% noninferiority margin potentially being too generous. Other members raised questions about the product’s safety with respect to Absorb in small vessels, as about half of scaffold thromboses occurred in small vessels.

In response, Abbott proposed the addition of a warning to the label, which would caution implanting a BVS in vessels with a reference vessel diameter (RVD) of <2.5 mm and a statement recommending online quantitative coronary angiography or intravascular imaging for small vessels assessed as < 2.75 mm. Further, panel members suggested Abbott incorporate a boxed warning and add information on use of Absorb in diabetics.

ABSORB III principal investigator Dr. Gregg Stone (Columbia University Medical Center, New York, NY) aimed to alleviate the panel’s safety concerns adding, “I think we’ve shown that there is reasonable effectiveness; we just have to ensure that it is implanted in the right patients.”

 

The agency is not obligated to follow its panel’s recommendation, but normally does so.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net

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