Svelte Medical awarded CE mark for its Direct RX stent


Svelte Medical has received the CE mark for the Direct sirolimus-eluting coronary stent rapid-exchange (RX) system for treating coronary artery disease. The new stent employs Discreet drug coating, composed of the well-studied drug sirolimus and a natural, amino acid-based polyesteramide (PEA) bioresorbable drug carrier (proprietary to DSM Biomedical).

A press release reports that this new class of drug coating is designed to be sufficiently tough to use with direct stenting, while higher durometer balloon material allows use of higher pressures to attain complete stent expansion, even in more highly calcified lesions.

Auke Weevers (Albert Schweitzer Ziekenhuis, Dordrecht, The Netherlands), who treated the first patient to receive the device, comments: “Direct RX provides smooth delivery and the stent conforms well to native vasculature. With its low-compliant balloon and bioresorbable drug coating technology designed for direct stenting, it is a nice compliment to Slender IDS, which we have already integrated into our practice.”

Slender IDS, which is commercially available at select accounts in Europe, combines Asahi guide wire technology and the same stent and balloon technology as Direct RX on a fixed-wire platform, creating an “all-in-one” system to further streamline percutaneous coronary intervention (PCI). Both Svelte platforms will be evaluated in the large, randomised, controlled, multicentre OPTIMIZE study expected to commence next year in support of commercial approvals in the US and Japan.