The first patient has been enrolled in Svelte Medical System‘s Optimize pivotal trial, which is designed to evaluate the safety and efficacy of Svelte’s drug-eluting stent integrated delivery system and rapid exchange platforms.
The 2,000-person trial comes in the wake of a first-in-man trial for Svelte’s product and a study comparing the system with Medtronic‘s (NYSE:MDT) Resolute Integrity drug-eluting stent. Patients in the feasibility trial finished five-year follow-up with zero reports of clinically-driven major adverse cardiovascular events.
In the Direct II trial comparing Medtronic’s device with Svelte’s, patients in the Svelte arm reported a 3.7% rate of clinically-driven MACE compared to 9.8% for those in the comparison arm.
Svelte’s integrated delivery system combines a sirolimus-eluting stent, balloon and a wire to reduce procedure time, radiation exposure and contrast use. The company touts its fixed-wire Svelte IDS as the world’s lowest profile drug-eluting stent. Both the IDS and rapid exchange platforms have CE Mark clearance and are commercially available in Europe.
“The profile, flexibility and overall deliverability of the Svelte system is remarkable,” Dr. J.D. Corl, the interventional cardiologist at Christ Hospital who treated the first patient in the Optimize trial, said in prepared remarks. “The added value of a low-compliant delivery balloon to deploy stents at higher pressures, reducing the need for traditional non-compliant post-dilatation balloons, is a real benefit to interventionalists.”
“Optimize will be a landmark study for interventional cardiology,” Dr. Dean Kereiakes, principal investigator and medical director at Christ Hospital, added.
“Not only is it evaluating an entirely new approach to coronary stent delivery utilizing novel concepts and next generation technologies, Optimize is the first trial to evaluate, in a prospective, randomized fashion, direct stenting as well as the potential health economic impact derived by streamlining PCI. Both the Optimize study and the new technology being evaluated are very exciting.”
“We are grateful to the Optimize study investigators for their collaboration and excited to bring our technologies to patients and physicians in the US and Japan,” Svelte president & CEO Jack Darby said. “Our highly differentiated platforms improve procedural efficiency and reduce cost while enhancing patient outcomes and comfort, delivering value to all constituents involved in coronary stenting – patients, physicians, providers and payers.”
