FDA Approves Svelte Medical Systems’ Bioresorbable Coated DES Systems

Svelte Medical Systems earned U.S. Food and Drug Administration (FDA) approval for its SLENDER IDS fixed-wire and DIRECT RX rapid-exchange drug-eluting stents (DES) to treat coronary artery disease. Both incorporate the same specialized stent, bioresorbable drug coating, and balloon technologies.
 
The devices’ OPTIMIZE IDE clinical study achieved 1.5 percent clinically-driven target lesion revascularization (TLR) at one year, the lowest ever reported for an investigational DES according to the company.
 
“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,” Dean Kereiakes, M.D., F.A.C.C., President of The Christ Hospital Heart & Vascular Institute in Cincinnati, Ohio, Clinical Professor of Medicine, The Ohio State University and co-principal investigator of the OPTIMIZE study, told the press. “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 U.S.”
 
SLENDER IDS is an integrated delivery system with Asahi guide wire tech, and DIRECT RX is a rapid-exchange system. The low profile DES systems enhance trans-radial intervention (TRI).
 
“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,” added Sunil Rao, M.D., F.A.C.C., Professor of Medicine at Duke University in Durham, North Carolina and co-principal investigator of the OPTIMIZE study. “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 U.S., approval of these products is very timely. I am excited to integrate them into my practice.”
 
30 percent of OPTIMIZE patients received direct stenting, with a 96 percent success rate. 80 percent of patients were treated with TRI. Direct stenting with SLENDER IDS experienced strong radiation exposure as well as procedure, device, and fluoroscopy times compared to direct stenting with a control DES.
 
“OPTIMIZE was a unique study—the first of its kind to evaluate a new mode of DES delivery, a new class of drug coating, direct stenting and TRI,” Jack Darby, president and CEO of Svelte Medical Systems told the press. “This not only generated outstanding data on investigational device performance, but also helped identify discrepancies between study definitions and assessments of myocardial infarction in clinical studies, which will help areas of future clinical research. We commend FDA for its timely and clear communications, understanding of technical and complex subject matter and true collaboration throughout the review process. We thank all OPTIMIZE investigators for their contribution to the study and look forward to our newly approved DES systems delivering unmatched value to all constituents of cardiac care in the United States—patients, physicians, providers, and payers.”