DIRECT II (Direct Implantation of Rapamycin-Eluting stents with bioresorbable drug Carrier Technology) is a prospective, randomized study that was undertaken in support of CE Mark certification of the Svelte IDS.
The drug-eluting stent study enrolled 159 patients at 18 clinical sites in Europe to evaluate the primary endpoints of target vessel failure and in-stent late loss.
All patients in the study were scheduled to receive six-month clinical and angiographic follow-up, with clinical follow-up continuing through five-years, with a subset of patients receiving optical coherence tomography imaging at six-months.
DIRECT II study builds upon the positive results of the DIRECT I first-in-man study where the Svelte drug-eluting coronary stent IDS continues to demonstrate durable outcomes with 0% clinically-driven MACE reported through two-years.
Svelte Medical Systems president and CEO Jack Darby said that the company is pleased to complete follow-up in DIRECT II and look forward to sharing the study outcomes with the interventional community later 2014.
"Our drug-eluting IDS represents the first advance in coronary stent delivery in more than 18-years, offering the ability to reduce access site size and maximize procedural efficiencies while providing durable long-term outcomes as good or better than the current market-leading drug-eluting stents," Darby added.
Svelte Medical Systems claims that Svelte IDS provides the lowest crimped stent profile on the market. The system combines a thin-strut cobalt chromium stent with a fully bioresorbable drug carrier made of amino acids found naturally in the human body and the well-studied compound sirolimus (rapamycin) mounted on an integrated-wire delivery system.
Incorporating Balloon Control Band technology, the IDS system provides uniform and controlled balloon growth, even at high pressures, to safely perform direct stenting as well as high-pressure post-dilatation.
