Trial of Biodegradable, Polymer Drug-Eluting Coronary Stent Completes Enrollment

Singapore-based Biosensors International Group’s Chinese subsidiary business, JW Medical Systems Ltd., tells us its CREDIT II stent study has completed 432 patient enrollment in China. CREDIT II is the first randomized controlled trial involving the EXCEL II biodegradable polymer drug-eluting coronary stent.

Background

Biodegradable polymer drug-eluting stents (BP-DES) aren’t exactly news, but EXCEL II is being touted by its purveyors as the latest generation in the EXCEL family, itself the leading BP-DES brand in China. The EXCEL II stent features an abluminal coating of sirolimus combined with an optimized PLA biodegradable polymer, and is deployed from a new delivery system.

CREDIT II is part of the Chinese EXCEL II clinical trial program which has enrolled over 1100 patients in three trials across 40 centers. Excel II’s First in Man study, CREDIT I, started enrollment in Mar 2013 and has completed one year follow-up.

Treatment with EXCEL II demonstrated excellent 4-month & 12-month late lumen loss and sustained effectiveness, with rapid endothelialization. Both OCT and angiographic results suggested outstanding safety and efficacy with EXCEL II. CREDIT I results were published in Catheterization and Cardiovascular Interventions earlier this year. A third trial, CREDIT III, is gathering data from a single arm registry that has enrolled 637 patients to date.

Company comments

“I am delighted to have completed patient enrollment in this important trial so quickly,” commented Principal Investigator Dr. Yaling Han, ShenYang PLA General Hospital, ShenYang, China. “The first generation EXCEL stent demonstrated excellent safety and efficacy. Based on that experience and the preliminary results of the CREDIT FIM trial, we expect even better long term safety and efficacy results from EXCEL II.”

Simon Li, CEO of JW Medical Systems (JWMS) added: “JWMS has been a leader in the Chinese drug eluting stent market for many years. The EXCEL II stent will continue that legacy, based on solid clinical evidence from studies such as CREDIT. ”

Source: PR Newswire

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