Svelte Medical Systems, Inc. Announces Enrollment Complete In The DIRECT II Drug-Eluting Stent Study

NEW PROVIDENCE, N.J.--(BUSINESS WIRE)--Svelte® Medical Systems today announced enrollment of the final patient in the DIRECT II (Direct Implantation of Rapamycin-Eluting stents with bioabsorbable drug Carrier Technology) clinical study. DIRECT II is a prospective, randomized study comparing the safety and efficacy of the Svelte drug-eluting coronary stent Integrated Delivery System (IDS) to the Medtronic Resolute Integrity™ drug-eluting stent in 159 patients at 19 investigative sites. The study builds on the positive results of the DIRECT I first-in-man study which evaluated the Svelte drug-eluting coronary stent IDS in 30 patients in New Zealand. The Svelte system met all study endpoints in DIRECT I while demonstrating in-stent neointimal volume obstruction of 2.7% at 6-months, a one-third to one-half reduction in volumetric obstruction observed in similar studies with market-leading drug-eluting stents. Clinical outcomes reflected the strong angiographic findings, with 0% clinically driven MACE reported through 18-months.

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