First Patient In The Svelte DIRECT Drug-Eluting Stent Study

Abstract

Svelte® Medical Systems has 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 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.

Background

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.

Cardiologist Comments

“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.”

Svelte’s full pres release can be found here.

Source: Svelte Medical Systems