Svelte Medical Systems has treated its first patient at Auckland City Hospital in Auckland, New Zealand, in the DIRECT study.
DIRECT is a first-in-man, multicentre clinical study that will involve 30 patients to evaluate the feasibility of Svelte’s All-In-One system.
The CE marked All-In-One system is a low profile flexible drug-eluting system that integrates a thin-strut cobalt chromium stent with a fully bio-erodable drug carrier and the drug Sirolimus (rapamycin).
Svelte’s drug delivery system incorporates a proprietary balloon control band technology providing uniform and controlled balloon growth, facilitating physicians to ‘direct-stent’ coronary artery lesions, while reducing procedure time and cost.
The company plans to market its drug-eluting stent on a conventional rapid-exchange delivery platform, and to expand it into larger studies in 2012.