NEW PROVIDENCE, N.J.--(BUSINESS WIRE)--Svelte® Medical Systems today announced treatment of the first patient in the DIRECT II (Direct Implantation of Rapamycin-Eluting stents with bioabsorbable drug Carrier Technology) study at Middelheim Hospital in Antwerp, Belgium. DIRECT II is a prospective, randomized, multi-center 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 builds on the 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 DIRECT I, the Svelte drug-eluting coronary 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.
