Svelte Medical Systems Completes DIRECT II Enrollment

November 14, 2013—Svelte Medical Systems, Inc. (New Providence, NJ) announced enrollment of the final patient in the DIRECT II clinical study of direct implantation of rapamycin (sirolimus)-eluting stents with bioabsorbable drug-carrier technology.

Svelte Medical Systems advised that the prospective, randomized DIRECT II trial is comparing the safety and efficacy of the Svelte coronary drug-eluting stent (DES) integrated delivery system (IDS) to the Medtronic Resolute Integrity DES (Medtronic, Inc., Minneapolis, MN) in 159 patients at 19 investigative sites. The DIRECT II study's primary endpoints are target vessel failure and in-stent late loss. All patients are scheduled to receive 6-month clinical and angiographic follow-up, with clinical follow-up continued through 5 years. A subset of patients will receive optical coherence tomography imaging at 6 months, reported the company.

According to the company, the study builds on the positive results of the DIRECT I first-in-man study, which evaluated the Svelte device in 30 patients in New Zealand and which met all study endpoints. Additionally, the device demonstrated 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 major adverse cardiovascular events reported through 18 months, stated Svelte Medical Systems.

The company advised that the fixed-wire Svelte DES IDS provides a low crimped stent profile. It navigates the vasculature similar to a traditional guidewire and facilitates use of the transradial approach. The system combines a thin-strut cobalt chromium stent with sirolimus and a new class of bioabsorbable drug carrier composed of naturally-occurring phenethylamine amino acids, which elicit a reduced inflammatory response compared with competitive poly(lactic-co-glycolic) acid technologies. Balloon control bands envelop the balloon shoulders. These bands provide a smooth leading edge during delivery and uniform, controlled balloon growth during deployment to safely perform direct stenting as well as high-pressure postdilatation. A rapid-exchange system incorporating these technologies will also be available at commercial launch.

“We are pleased to have completed this rigorous evaluation of the Svelte DES IDS following the strong and sustained outcomes of the DIRECT I study,” commented Stefan Verheye, MD, in the company's press release. “As continued emphasis is placed on downsizing access sites and improving procedural efficiencies as well as clinical outcomes, this system presents an important option to interventional cardiologists.”

Dr. Verheye, who is Co-Director of the Antwerp Cardiovascular Institute at the Middelheim Hospital in Antwerp, Belgium, shared interim findings from the DIRECT II study in October at the TCT 2013: Transcatheter Cardiovascular Therapeutics meeting in San Francisco, California.