Svelte Medical Systems said today it won CE Mark approval in the European Union for its Slender sirolimus-eluting coronary stent-on-a-wire integrated delivery system designed to treat coronary artery disease.
The Slender IDS is the lowest-profile drug-eluting stent on the market, according to the New Providence, N.J.-based company. Approval in the EU came based on data from the Direct I and Direct II clinical studies of the device.
“Slender IDS is an entirely new approach to coronary stenting, offering unique clinical and procedural benefits which we look forward to integrating into our practice. No reports of stent thrombosis dating back nearly 4 years to the 1st-in-man study are reassuring signals relating to safety, and product efficacy appears as good as any current generation DES. The unique attributes of this product help us in our ongoing efforts to optimize patient care,” principal investigator Dr. Stefan Verheye of Belgium’s Antwerp Cardiovascular Institute at the Middelheim Hospital said in a press release.
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.
“Adding value in the modern healthcare environment requires new technologies to improve efficiency and reduce cost while enhancing patient outcomes and comfort. Slender IDS is a highly differentiated platform delivering value to all constituents involved in coronary stenting – patients, physicians, providers and payers. We are extremely pleased to achieve the CE Mark for Slender IDS and look forward to introducing it in cath labs in Europe,” CEO Jack Darby said in prepared remarks.
Svelte Medical siad it plans to commercialize the device in select European markets and will commence an investigational device exemption study to support premarket approval with the FDA in 2016.
The company said it has plans for a rapid-exchange DES system for direct stenting to be on the market in Europe in 2016.