Svelte Medical Systems Gets CE Mark for Sirolimus-Eluting Stent

New Providence, N.J.-based Svelte Medical Systems Inc. has earned CE Mark certification for its Slender Sirolimus-Eluting Coronary Stent-On-A-Wire Integrated Delivery System (IDS) for the treatment of coronary artery disease. The first advance in stent delivery since the rapid-exchange catheter, Slender IDS is the world’s lowest profile drug-eluting stent (DES), reducing the catheter size necessary to perform percutaneous coronary intervention (PCI) and facilitating transradial intervention (TRI) in more patients. Incorporating Asahi guide wire technology, a specialized balloon design and a new class of bioresorbable drug carrier from DSM Biomedical, Slender IDS is designed to enhance direct stenting, enabling interventional cardiologists to extracts steps, time and cost from stenting procedures.

Sirolimus is an immunosuppressant drug often used to prevent rejection in organ transplants.

“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,” said Stefan Verheye, M.D., Ph.D., principal investigator of the Direct II study supporting CE Mark certification and co-director of the Antwerp Cardiovascular Institute at the Middelheim Hospital in Antwerp, Belgium. “No reports of stent thrombosis dating back nearly 4 years to the first-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.”

Slender IDS combines the latest guide wire, delivery balloon and DES technologies into a single ‘all-in-one’ fixed-wire system. 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 3 years.

“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,” said Jack Darby, president and CEO of Svelte Medical Systems. “We are extremely pleased to achieve the CE Mark for Slender IDS and look forward to introducing it in cath labs in Europe.”

Svelte plans to commercialize Slender IDS in select accounts in Europe and commence an IDE study in support of U.S. Food and Drug Administration pre-market approval in 2016. A rapid-exchange DES system with proprietary technology designed to facilitate direct stenting will also be commercialized in Europe in 2016.

Svelte Medical Systems is focused on creating highly deliverable balloon expandable stents.