Svelte treats first patient in DIRECT study
Svelte Medical Systems has treated its first patient at Auckland City Hospital in Auckland, New Zealand, in the DIRECT study.
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.