New Jersey based Svelte® Medical Systems has announced treatment of a first patient in the DIRECT II study into its drug-eluting stent.
Direct II (Direct Implantation of Rapamycin-Eluting stents with bioabsorbable drug Carrier Technology) is a prospective, randomised, multi-centre clinical study comparing the safety and efficacy of the Svelte drug-eluting coronary stent Integrated Delivery System (IDS) to Medtronic’s Resolute Integrity™ drug-eluting stent.
The study will enroll 159 patients at up to 20 clinical sites in Europe and Brazil to assess the primary endpoints of Target Vessel Failure (TVF) and in-stent Late Loss (LL). All patients are scheduled to receive 6-month clinical and angiographic follow-up, with clinical follow-up through 5-years. A subset of patients will also receive optical coherence tomography (OCT) imaging at 6-months.
Svelte says the study builds on positive 6-month results of the DIRECT I first-in-man study which evaluated the Svelte drug-eluting coronary stent IDS in 30 patients in New Zealand. In that study the Svelte stent IDS met all study endpoints and demonstrated in-stent neointimal volume obstruction of 2.7% as assessed by intravascular ultrasound (IVUS), which is one-third to one-half the volumetric obstruction observed in market-leading drug-eluting stent first-in-man studies. That is consistent with Svelte’s claim that it has the lowest crimped stent profile on the market. Svelte’s offering combines a thin-strut cobalt chromium stent with a fully bioabsorbable amino acid drug carrier.
“The Svelte IDS offers a unique approach to percutaneous coronary intervention and we look forward to evaluating the performance of the drug-eluting platform in this highly scientific clinical study,” said Stefan Verheye, MD, PhD and co-director of the Antwerp Cardiovascular Institute at the Middelheim Hospital in Antwerp. “We have experience with the bare-metal version of the IDS, and the system’s low profile and unique balloon technology have allowed us to direct stent both simple and complex lesions.”
“We are excited to have the DIRECT II study underway and wish to thank our outstanding group of investigators for their collaboration in this effort,” said Jack Darby, President and CEO of Svelte Medical Systems. “We believe our drug-eluting IDS, with its proprietary balloon and drug carrier technologies, represents an easy to use, best-in-class offering which will deliver procedural efficiencies and associated cost savings while demonstrating long-term clinical outcomes consistent with market-leading drug-eluting stents.”
Source: Svelte Medical, Inc., Business Wire