News | Stents | October 28, 2016

Svelte Medical Systems Announces CE Mark Certification of Direct RX

Sirolimus-eluting coronary stent combines new class of bioresorbable drug coating, highly conformable stent design and proprietary balloon technology to provide a workhorse coronary drug-eluting stent rapid-exchange system designed to enhance direct stenting

Svelte Medical Systems, CE Mark, Direct RX, Direct sirolimus-eluting coronary stent rapid exchange system, drug-eluting stent, DES

October 28, 2016 — Svelte Medical Systems Inc. announced this week it received CE Mark certification of the Direct Sirolimus-Eluting Coronary Stent Rapid-Exchange (RX) System for the treatment of coronary artery disease. The first patient to receive Direct RX was treated by Auke Weevers, M.D., a practicing interventional cardiologist at Albert Schweitzer Ziekenhuis in Dordrecht, The Netherlands.

“Direct RX provides smooth delivery and the stent conforms well to native vasculature. With its low-compliant balloon and bioresorbable drug coating technology designed for direct stenting, it is a nice compliment to Slender IDS [Integrated Delivery System], which we have already integrated into our practice,” said Weevers.

Adding value in the modern healthcare environment requires new technologies to improve efficiency and reduce cost while enhancing patient outcomes and comfort. Direct RX employs DISCREET drug coating, composed of the well-studied drug sirolimus and a natural, amino acid-based polyesteramide (PEA) bioresorbable drug carrier proprietary to DSM Biomedical. This new class of drug coating is sufficiently tough to use with direct stenting, while higher durometer balloon material allows use of higher pressures to attain complete stent expansion, even in more highly calcified lesions. Use of the direct stenting approach minimizes use of pre-dilatation balloons, reducing the time and cost of stent procedures. Direct RX is specifically indicated for use with the direct stenting approach and in diabetic patients.

Slender IDS, which is commercially available at select accounts in Europe, combines Asahi guide wire technology and the same stent and balloon technology as Direct RX on a fixed-wire platform, creating an ‘all-in-one’ system to further streamline percutaneous coronary intervention (PCI).

Both Svelte platforms will be evaluated in the large, randomized, controlled, multi-center OPTIMIZE study expected to commence next year in support of commercial approvals in the United States and Japan.

For more information: www.sveltemedical.com

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