FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals / Research and Development

Abbott Releases Clinical Results of Absorb III Trial

Oct. 15, 2015

Healthcare company Abbott has released the one-year clinical results of its Absorb III trial comparing the safety and efficacy of Abbott’s fully dissolving Absorb heart stent to Xience, the company’s metallic drug eluting stent.

The trial met its primary endpoint of target lesion failure of 7.8 percent for Absorb compared to 6.1 percent for Xience. The data demonstrate that both devices are comparable in treating people with coronary artery disease, the Illinois-based company says.

The results will be used to support efforts to obtain regulatory approval in the U.S.

The 2,000-patient trial was conducted at 193 sites, primarily in the U.S. — Michael Cipriano