Bioresorbable stent system receives CE Mark for treatment of CAD

Abbott announced that its bioresorbable stent system was granted a CE Mark for the treatment of patients with CAD, according to a press release.

The Absorb GT1 stent system combines a fully dissolving stent and a next-generation delivery catheter intended to ease the access and treatment of diseased vessels in patients with CAD. The bioresorbable vascular scaffold delivers everolimus on implantation, but dissolves over time. The device dissolves completely, with the exception of two metallic markers that guide initial placement and allow physicians to determine where the scaffold had been located, according to the release.

The CE Mark follows 1-year results from the prospective, randomized ABSORB II trial, results of which were presented at TCT 2014 and indicated comparable safety and efficacy with the Absorb system compared with the Xience everolimus-eluting stent in 501 patients with CAD. The company will also presenting additional data on the Absorb system this week during the EuroPCR conference in Paris, according to the release.

“Dissolving stents are the next logical step in the treatment of patients with CAD as these stents completely dissolve after opening up clogged arteries and restoring blood flow,” Christoph K. Naber, MD, PhD, director of the Contilia Heart and Vascular Centre in Essen, Germany, said in the release. “With the prevalence of CAD around the world, this therapy has the potential to improve the health of many people.”

The Absorb system is available in more than 70 countries worldwide, but is currently an investigational device not approved for commercial use in the United States.

Disclosure: Naber is a consultant for Abbott.