Svelte Medical’s Slender IDS and Direct RX Bioresorbable Coated DES Systems Approved by FDA

December 14, 2021—Svelte Medical Systems announced FDA approval to commercialize the company’s Slender IDS fixed-wire and the Direct RX rapid-exchange drug-eluting stent (DES) systems for the treatment of coronary artery disease in the United States.

Slender IDS is an all-in-one integrated delivery system featuring Asahi guidewire technology (Asahi Intecc). Direct RX is a workhorse rapid-exchange delivery system. Both devices are low-profile DES systems designed to enhance transradial intervention (TRI) and indicated by the FDA for use with direct stenting.

The company noted that the devices, which incorporate the same specialized stent, bioresorbable drug coating, and balloon technologies, achieved 1.5% clinically driven target lesion revascularization at 1 year in the OPTIMIZE investigational device exemption clinical study. In OPTIMIZE, direct stenting was undertaken in 30% of patients, with a 96% device success rate, and 80% of study patients were treated via TRI. In addition to strong procedural and clinical outcomes, investigators with previous experience in direct stenting with Slender IDS in Europe realized significant reductions in radiation exposure and procedure, device, and fluoroscopy times compared with direct stenting using control DES.

Dean Kereiakes, MD, and Sunil Rao, MD, serve as Coprincipal Investigators of the OPTIMIZE study. Dr. Kereiakes is President of The Christ Hospital Heart & Vascular Institute in Cincinnati, Ohio, and Clinical Professor of Medicine at The Ohio State University in Columbus, Ohio. Dr. Rao is Professor of Medicine at Duke University in Durham, North Carolina.

“Slender IDS and Direct RX are extremely low-profile, highly deliverable DES systems that provide excellent early and long-term clinical outcomes in complex patient populations,” commented Dr. Kereiakes in the company’s press release. “Slender IDS uses a unique DES delivery platform, while both systems incorporate a novel drug carrier and other technologies, which I believe will add value in the treatment of patients in the United States.”

Dr. Rao added, “Materially lower system and crossing profiles facilitate TRI, which, when combined with a direct stenting approach in appropriate clinical indications, streamline procedures, limit complications, and enhance patient experience. TRI has been long regarded as the standard of care overseas. With its increased adoption and use in the majority of cases recently in the United States, approval of these products is very timely. I am excited to integrate them into my practice.”