Svelte Medical Systems said today that it received CE Mark approval in the European Union for its Direct sirolimus-eluting coronary stent.
The stent uses a coating of sirolimus and a natural, amino acid-based polyesteramide bioresorbable drug carrier. Direct stenting minimizes the use of pre-dilation balloons, lessening the cost and time of stent procedures. Direct Rx is specifically indicated for use with the direct-stenting approach and in diabetic patients, Svelte reported.
The Direct Rx system and Svelte’s Slender IDS platform will be evaluated in a randomized, multi-center study. The Optimize study is expected to begin next year in support of commercial approvals in the U.S. and Japan, according to the company.
“Direct Rx provides smooth delivery and the stent conforms well to native vasculature,” Dr. Auke Weevers, of Albert Schweitzer Ziekenhuis in Dordrecht, Holland, said in prepared remarks. “With its low-compliant balloon and bioresorbable drug coating technology designed for direct stenting, it is a nice compliment to Slender IDS which we have already integrated into our practice.”
“With more than 4 years of follow-up in clinical studies demonstrating no cases of stent thrombosis and low rates of neointimal proliferation, our DES continues to demonstrate exceptional and sustained outcomes. Direct Rx compliments our Slender IDS technology, providing a more conventional stent delivery platform for cases where our stent-on-a-wire technology may not be optimally suited,” added president & CEO Jack Darby. “Svelte DES technologies can now be used to treat all lesions suitable for coronary stenting. We look forward to bringing this technology to more patients in Europe.”
The New Providence, N.J.-based company won CE Mark approval for its Slender sirolimus-eluting coronary stent-on-a-wire integrated delivery system last December and launched in Europe in January 2016.
