Svelte Medical Systems Inc. has announced the commercial launch of the Slender Sirolimus-Eluting Coronary Stent-On-A-Wire Integrated Delivery System (IDS) to select accounts in Europe specializing in TRI. The first advance in stent delivery since the rapid-exchange catheter, Slender IDS is the world’s lowest profile drug-eluting stent (DES), designed to reduce the catheter size and steps necessary to perform percutaneous coronary intervention (PCI), according to the company.

“Slender IDS will result in a paradigm shift in interventional cardiology,” said Ferdinand Kiemeneij, M.D., Ph.D., who treated the first patient with the recently CE Mark certified Slender IDS at Tergooi Hospital in Blaricum, The Netherlands, and was the first interventional cardiologist ever to perform PCI via transradial approach more than 20 years ago. “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.”

By combining the latest guide wire, delivery balloon, stent and drug coating technologies into a single ‘all-in-one’ fixed-wire system, Slender IDS achieves low profiles and performance unlike any other DES. Asahi Act One wire technology provides precise steering while proprietary Balloon Control Band (BCB) technology allows controlled balloon growth to safely perform direct stenting and high-pressure post-dilatation(s). Discreet drug coating, applied to a highly conformable cobalt chrome stent, is composed of the well-studied drug sirolimus and a natural, amino acid-based polyesteramide (PEA) bioresorbable drug carrier proprietary to DSM Biomedical, a global leader in biomaterials science and regenerative medicine. In the Direct I and II clinical studies, exceptionally low TLR was observed while no deaths or stent thromboses were reported beyond three years.

“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,” said Giovanni Amoroso, M.D., Ph.D., a practicing interventional cardiologist at OLVG Hospital in Amsterdam, The Netherlands, and principal investigator of the DIRECT III post-market study evaluating the clinical and procedural efficiency of Slender IDS in a real world setting.

Svelte plans to begin enrollment of the Direct III post-market study during the first quarter of this year to evaluate the procedural efficiencies and 12-month clinical outcomes of Slender IDS in real-world patient populations in Europe. A rapid-exchange DES system with proprietary technology designed to facilitate direct stenting will also be commercialized in Europe in 2016. Svelte further plans to commence an IDE study in support of U.S. pre-market approval in 2016.

“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,” said Jack Darby, president/CEO of Svelte Medical Systems.

Headquartered in New Providence, N.J., Svelte Medical Systems is a privately-held company engaged in the development of highly deliverable balloon expandable stents.

Watch the video below to learn more about Svelte’s Slender IDS: