CE mark for Svelte Medical’s sirolimus-eluting coronary stent-on-a-wire integrated delivery system


Svelte Medical Systems has received the CE mark for its Slender sirolimus-eluting coronary stent-on-a-wire integrated delivery system for the treatment of coronary artery disease. The company claims that the device is the world’s lowest profile drug-eluting stent, reducing the catheter size necessary to perform percutaneous coronary intervention (PCI) and facilitating transradial intervention in more patients.

A press release reports that the device incorporates Asahi guidewire technology, a specialised balloon design and a new class of bioresorbable drug carrier from DSM Biomedical. It adds that the Slender integrated delivery system is designed to enhance direct stenting, enabling interventional cardiologists to extracts steps, time and cost from stenting procedures.

Additionally, the Slender integrated delivery system combines the latest guidewire, delivery balloon and drug-eluting stent technologies into a single “all-in-one” fixed-wire system. According to the press release, Asahi Act One wire technology provides precise steering while proprietary balloon control band 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 bioresorbable drug carrier (proprietary to DSM Biomedical). In the DIRECT I and II clinical studies, exceptionally low target lesion revascularisation was observed while no deaths or stent thromboses were reported beyond three years.

Stefan Verheye (director of the Antwerp Cardiovascular Institute at the Middelheim Hospital in Antwerp, Belgium), principal investigator of the DIRECT II study, says: “The Slender integrated delivery system 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 four years to the first-in-man study are reassuring signals relating to safety, and product efficacy appears as good as any current generation drug-eluting stent. The unique attributes of this product help us in our ongoing efforts to optimize patient care.”

Svelte plans to commercialise the system in select accounts in Europe and commence an IDE study in support of PMA approval in 2016. A rapid-exchange drug-eluting stent system with proprietary technology designed to facilitate direct stenting will also be commercialised in Europe in 2016.