China-based Shanghai Bio-Heart Biological Technology Co., Ltd (HKG: 2185) announced that the BIOHEART-II study for its bioresorbable scaffolds (BRS) product BIOHEART in coronary heart disease has reached its pre-set primary endpoint.
Study Details
The prospective, multi-center, randomized-controlled study enrolled 431 patients, with Abbott Laboratories’ Xience everolimus-eluting coronary stent as the control. The study showed that the drug reached the primary clinical endpoint of efficacy, which is in-segment late lumen loss at 12 months after the operation, and was non-inferior to the control group.
Safety Profile
In this study, patients using a Bioheart bioabsorbable coronary rapamycin-eluting stent had a similar safety profile to patients using control stents, with no increased risk of adverse events such as myocardial infarction, death, and no stent thrombosis.
Market Context
There are only two fully degradable stent products on the market in China, both first-generation products with pillar thickness in excess of 150 microns. Bioheart is expected to be the world’s first second-generation fully degradable stent system to receive regulatory approval based on the results of a multi-center randomized controlled clinical trial. It obtained fast-track status in China in February 2017.-Fineline Info & Tech
