Svelte Medical's Slender IDS Receives CE Mark Approval

December 15, 2015—Svelte Medical Systems, Inc. announced it has received European CE Mark approval of the Slender sirolimus-eluting coronary stent-on-a-wire integrated delivery system (IDS) for the treatment of coronary artery disease. Slender IDS combines the latest guidewire, delivery balloon, and drug-eluting stent (DES) technologies into a single ‘all-in-one’ fixed-wire system. The company will begin to market the Slender IDS in select accounts in Europe. 

CE Mark approval of the Slender IDA was supported by the DIRECT I and DIRECT II  clinical studies that demonstrated exceptionally low target lesion revascularization rates, and no deaths or stent thromboses were reported beyond 3 years.

Additionally, the company advised that it will commence an investigational device exemption study in the United States in 2016 to support US Food and Drug Administration premarket approval. Also in 2016, Svelte Medical will begin commercialization in Europe of a rapid-exchange DES system that is designed to facilitate direct stenting.

According to Svelte Medical, the very low-profile Slender IDS DES reduces the catheter size necessary to perform percutaneous coronary intervention and facilitates transradial intervention in more patients. Designed to enhance direct stenting, the Slender IDS incorporates Asahi guidewire technology, a specialized balloon design, and a new class of bioresorbable drug carrier. 

Asahi’s Act One wire technology provides precise steering and the BCB balloon control band technology allows controlled balloon growth to safely perform direct stenting and high-pressure postdilatation. The Discreet drug coating, applied to a highly conformable cobalt chrome stent, is composed of sirolimus and DSM Biomedical’s natural, amino acid-based polyesteramide bioresorbable drug carrier. 

In February 2015, Svelte Medical and Asahi Intecc announced manufacturing and branding agreements that include using Asahi’s ActOne wire technology in the design, development, and supply of core wire and coil assemblies for the Svelte’s IDS.

In the company’s press release, Stefan Verheye, MD, the Principal Investigator of the DIRECT II study, commented, “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 first-in-human 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.” Dr. Verheye is Co-Director of the Antwerp Cardiovascular Institute at the Middelheim Hospital in Antwerp, Belgium.