Svelte Medical Systems said today it initiated a select launch of its Slender sirolimus-eluting coronary stent-on-a-wire integrated delivery system in Europe.
The device incorporates Japan’s Asahi Intecc (TYO:7747) guide wire technology, specialized balloon design and a bioresorbable drug carrier from DSM Biomedical. The Slender’s all-in-one’ fixed-wire system with combined technologies allows for “precise steering” and controlled balloon growth for performing direct stenting in high-pressure post-dilations, Svelte Medical said.
“Slender IDS is a highly differentiated platform that fundamentally changes the way coronary stenting procedures are performed, and it will ultimately transform the DES landscape. We are excited to see physicians in the real-world share our enthusiasm for this novel platform,” CEO Jack Darby said in a press release.
The Slender IDS is the lowest-profile drug-eluting stent on the market, according to the New Providence, N.J.-based company.
“Slender IDS will result in a paradigm shift in interventional cardiology. Slender IDS is a platform designed to improve patient care by breaking with current interventional standards, and I am proud to be involved with this project,” Dr. Ferdinand Kiemeneij said in prepared remarks.
The company said results from its previous Direct I and II studies of the device indicated low rates of target lesion revascularization and no deaths or stent thromboses beyond 3 years.
Svelte Medical said it plans to begin enrollment for its next Direct III post-market study of the device in the 1st quarter this year, hoping to evaluate the “procedural efficiencies and 12-month clinical outcomes” of the device in real-world populations in Europe.
“Downsizing is the future of interventional cardiology, and Slender IDS is the first ultra-low profile DES. The ability to reduce catheter size without compromise to performance minimizes vascular trauma and enables use of the transradial approach, with all of its well-known clinical benefits, across broader subsets of patients. This makes for a much more pleasant patient experience,” Direct III post market study principal investigator Dr. Giovanni Amoroso of Amsterdam’s OLVG Hospital said in a prepared statement.
Svelte Medical said it plans to initiate an IDE study as it aims for U.S. premarket approval sometime this year.
