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Tuesday, July 5, 2022

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Svelte Medical Systems Receives FDA Approval For SLENDER IDS® And DIRECT RX® Bioresorbable Coated Drug-Eluting Stent Systems

World’s Lowest Profile Drug-Eluting Stent Systems with the Lowest Rate of 1 Year Reintervention Reported in a U.S. Pivotal Study Now Approved for Use in U.S. Patients

Svelte Medical Systems received U.S. Food and Drug Administration (FDA) approval to commercialize the SLENDER IDS® fixed-wire and DIRECT RX® rapid-exchange drug-eluting stent (DES) systems for the treatment of coronary artery disease in the U.S. SLENDER IDS® and DIRECT RX®, incorporating the same specialized stent, bioresorbable drug coating and balloon technologies, achieved 1.5% clinically-driven Target Lesion Revascularization (TLR) at 1 year in the OPTIMIZE Investigational Device Exemption (IDE) clinical study, the lowest ever reported with an investigational DES.

“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. 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.,” said 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.

SLENDER IDS®, an ‘all-in-one’ integrated delivery system featuring Asahi guide wire technology, and DIRECT RX®, a workhorse rapid-exchange delivery system, are low profile DES systems designed to enhance trans-radial intervention (TRI) and indicated by the FDA for use with direct stenting.

“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.”

Direct stenting was undertaken in 30% of OPTIMIZE subjects, with 96% device success rates observed. Eighty percent of study subjects were treated via TRI. In addition to strong procedural and clinical outcomes, investigators with prior experience 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.

“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. 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,” said Jack Darby, President and CEO of Svelte Medical Systems. “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.”

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