DES systems to facilitate transradial PCI receive FDA approval
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Svelte Medical Systems announced the FDA approved two of its drug-eluting stent systems designed to facilitate transradial PCI.
The systems (Slender IDS and Direct RX, Svelte) incorporate a stent, a bioresorbable drug coating and a balloon technology and are approved to treat patients with CAD, according to a press release issued by the company.
Slender IDS has an integrated delivery system featuring a guidewire technology from Asahi Medical, and Direct RX is a rapid-exchange delivery system, and both are low-profile systems designed to enhance transradial PCI and are indicated for direct stenting, according to the release.
The approval was based on the OPTIMIZE IDE trial, in which the systems had a 1-year rate of target lesion revascularization of 1.5%, the lowest reported for an investigational DES, the company stated in the release.
“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, MD, FACC, FSCAI, president of The Christ Hospital Heart & Vascular Institute in Cincinnati, clinical professor of medicine at The Ohio State University and co-principal investigator of the OPTIMIZE study, said in the 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 U.S.”
“Materially lower system and crossing profiles facilitate transradial intervention, which, when combined with a direct stenting approach in appropriate clinical indications, streamline procedures, limit complications and enhance patient experience,” Sunil Rao, MD, FSCAI, FACC, professor of medicine at Duke University and co-principal investigator of the OPTIMIZE study, said in the release. “Transradial intervention 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.”
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