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.
Providing the lowest crimped stent profile on the market, the fixed-wire Svelte drug-eluting stent IDS navigates the vasculature similar to a traditional guidewire and facilitates use of the trans-radial approach. The system combines a thin-strut cobalt chromium stent with the well-studied compound sirolimus (rapamycin) and a new class of bioabsorbable drug carrier composed of naturally-occurring amino acids (PEAs) which elicit a reduced inflammatory response compared with competitive (PLGA) technologies. Proprietary Balloon Control Bands (BCBs) envelop the balloon shoulders to provide a smooth leading edge during delivery and uniform, controlled balloon growth during deployment to safely perform direct stenting as well as high-pressure post-dilatation. A rapid-exchange system incorporating these proprietary technologies will also be available at commercial launch.