Abbott Closer to FDA Approval of Absorb Stent

The independent panel of experts convened by FDA decided that the benefits of Abbott's Absorb bioresorbable drug eluting coronary stent outweigh the risks.

Nancy Crotti

An FDA advisory committee has voted that the benefits of a bioabsorbable cardiac stent designed by Abbott outweigh the risks, according to the company.

FDA could issue a PMA for the Absorb fully resorbable stent in the fourth quarter of this year, a stock market analyst from RBC Capital predicted in a report in financial news outlet The Fly. The analyst added that Absorb would likely be a "niche device," pending longer-term data, the report said.

The FDA panel also voted 9 to 1 in favor of the device's safety and 10 to 0 on its efficacy, the company said. Panel members reviewed data from multiple studies of the Absorb dissolving stent.

Prospects for the technology appear uncertain after a recent clinical trial found that the technology was merely "noninferior" to Abbott's metallic Xience drug-eluting stent. Despite the fact that the Absorb did not prove itself to be superior to the Abbott Xience stent, non-inferiority was the primary endpoint of the clinical trial.

The trial found that patients who received an Absorb dissolving stent experienced comparable rates of specific adverse events--including heart disease-related death, heart attacks attributed to the stented artery, and repeat procedures--as compared to patients who received the Xience stent.

Bioabsorbable stents have been hailed as one of the most promising technologies in cardiology for the past 10 years or so. Last year, Boston Scientific beat Abbott to become the first company to market bioabsorbable polymer stents in the U.S.

In a submission to FDA, Abbott described the Absorb GT1 Bioresorbable Vascular Scaffold as "a temporary coronary scaffold comprised of a fully bioresorbable scaffold and bioresorbable polymer coating" that is "naturally resorbed by the body in two to three years." Metal stents are permanent implants that restrict arterial motion for the life of the patient.

"In multiple randomized clinical trials, the Absorb bioresorbable vascular scaffold has demonstrated comparable outcomes to the leading permanent metallic stent," said Gregg W. Stone, MD, director of cardiovascular research and education at the Center for Interventional Vascular Therapy, Columbia University Medical Center and New York-Presbyterian Hospital. "As a first-in-kind device with novel properties, including complete dissolution and natural restoration of vessel function, this is a remarkable achievement."

Stone chaired the Absorb clinical trial program.Abbott submitted its PMA application for the Absorb dissolving stent in mid-2015 to FDA, which convened the advisory committee. The company expects a decision on the PMA later this year.

The latest news about Absorb provides some good news for Abbott--especially welcome after recent problems with another cutting-edge technology out of Abbott, its MitraClip percutaneous mitral valve repair system

One month ago, FDA announced that Abbott Vascular has received nine reports of its MitraClip delivery system failing to detach from the Clip, which resulted in the death of one patient and open-heart surgery to extract the device. The problem can also cause its mandrel component to fracture.

Abbott recalled the delivery system and provided updated instructions and training for clinicians using the device.

Nancy Crotti is a contributor to Qmed and MPMN.

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