New Providence, N.J.-based Svelte Medical Systems won conditional approval from the FDA to launch a pivotal human trial of its Svelte coronary stent Integrated Delivery System, designed to streamline stenting and thereby reduce procedure time and cost.
Svelte won approval to enroll around 370 patients at up to 30 U.S. sites to evaluate the safety and effectiveness of its IDS, which combines a wire, balloon and stent into an all-in-one low-profile and highly flexible system.
"Given the ever-increasing time constraints and cost pressures confronting cardiac cath labs, we are very confident the Svelte IDS offers an impactful alternative to maximize efficiency while providing best-in-class technology and outcomes," Svelte president & CEO Jack Darby said in prepared remarks.
Darby took over as CEO earlier this month, replacing Mark Pomeranz who stayed with Svelte as its chief operating officer.
The privately held company has CE Mark approval in the European Union for directing bare-metal stent implantation with the IDS, according to a press release.
Svelte earlier this year completed enrollment in the Direct 1st-in-man study evaluating its semi-resorbable drug-eluting stent, and the company hopes to launch a European-based clinical trial in supports of CE Marking for the DES later this year. The DES will be available with IDS delivery as well as traditional platforms using the company’s proprietary Balloon Control Band technology, according to a company statement.
That’s good news for Svelte, which stands to lose some of its royalty revenues after re-negotiating rates with stent maker InspireMD (OTC:NSPR). InspireMD traded about $1.8 million of its common stock for lower royalty rates on its MGuard Prime stents, which dropped to 2.9% on worldwide sales. Previous rates were 7% outside the U.S. and a high of 10% after FDA approval, according to a separate press release.
