Svelte Medical Systems has received CE mark approval for its Direct sirolimus-eluting coronary stent rapid-exchange (RX) system to treat coronary artery disease.
The system features Discreet drug coating, which is composed of drug sirolimus and amino acid-based polyesteramide (PEA) bioresorbable drug carrier proprietary to DSM Biomedical.
It has been designed for use with the direct stenting approach and in diabetic patients.
According to the company, the stenting approach minimizes use of pre-dilatation balloons, as well as reduces time and cost of stent procedures.
Svelte Medical Systems president and CEO Jack Darby said: “With more than four years of follow-up in clinical studies demonstrating no cases of stent thrombosis and low rates of neointimal proliferation, our DES continues to demonstrate exceptional and sustained outcomes.
“DIRECT RX compliments our SLENDER IDS technology, providing a more conventional stent delivery platform for cases where our stent-on-a-wire technology may not be optimally suited.”
Commercially available at select accounts in Europe, The Slender IDS combines Asahi guide wire technology and the same stent and balloon technology as Direct RX RX on a fixed-wire platform.
Both platforms will be assessed in the randomized and multi-center Optimize study, which is expected to begin in next year to support commercial approvals in the US and Japan.
Based in New Providence of New Jersey, Svelte Medical Systems is involved in the development of advanced deliverable balloon expandable stents.