Svelte® Medical Systems today announced treatment of the first patient in the DIRECT (Direct-on-a-wire Implantation of Rapamycin-eluting stent with bio-Eroding Carrier Technology) study at Auckland City Hospital in Auckland, New Zealand. DIRECT is a First-In-Man, multi-center clinical study designed to assess the feasibility of Svelte's novel 'All-In-One' system, which combines a thin-strut cobalt chromium stent with a fully bio-erodable drug carrier and the well-studied sirolimus (rapamycin) drug, mounted on Svelte's novel fixed-wire delivery system. The 'All-In-One' system is low profile and highly flexible, navigating through the vasculature similar to a traditional guidewire, allowing physicians to 'direct-stent' coronary artery lesions and eliminate several steps in their current stenting procedures, thereby reducing procedure time and cost.
“The non-inflammatory and non-thrombogenic drug carrier has high mechanical integrity, yet fully erodes within a year. These unique properties should provide important clinical benefits, and we are very excited to put this new technology in the hands of our outstanding group of clinical investigators.”
"The Svelte 'All-In-One' drug-eluting platform offers a novel and potentially improved method of stent delivery coupled with a unique, bio-friendly drug carrier, which can have positive and meaningful clinical and practical impact for both patients and physicians," said Mark Webster, MBChB, an interventional cardiologist at Auckland City Hospital and principal investigator for the DIRECT study. John Ormiston, MBChB and Tim Glenie, MBChB, also practicing interventional cardiologists at Auckland City Hospital, performed the first case of the study. "We are pleased to have treated the first patient in the world with the Svelte drug-eluting stent and are very impressed with how easy the system is to use," noted Dr. Ormiston. "We look forward to further evaluating the Svelte system."
The Svelte 'All-In-One' system utilizing a bare metal stent platform received CE Mark notification in August of last year, and is commercially available in select European and Latin American markets. The drug-eluting stent system will be evaluated in 30 patients in the DIRECT study, and the company plans to expand into larger studies next year.
As a fixed-wire design, the Svelte 'All-In-One' system achieves lower profile and greater flexibility, facilitating use of the transradial approach and general downsizing of the access site, while allowing access to more difficult to cross and distal lesions. The system also includes proprietary balloon control band technology providing uniform and controlled balloon growth, even at high pressures, to safely facilitate direct stenting and use of the system for post-dilatation. Data from Europe demonstrate the Svelte system significantly reduces radiation exposure, contrast use, adjunctive interventional product use and overall procedure time when compared with conventional stent systems.
"Our next generation drug-eluting stent system is designed to couple the benefits of enhanced deliverability and time and cost savings with the low restenosis rates associated with the latest generation drug-eluting stents," said Mark Pomeranz, President and CEO of Svelte Medical Systems. "The non-inflammatory and non-thrombogenic drug carrier has high mechanical integrity, yet fully erodes within a year. These unique properties should provide important clinical benefits, and we are very excited to put this new technology in the hands of our outstanding group of clinical investigators."