NEW PROVIDENCE, N.J.–(BUSINESS
WIRE)–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
Sveltes 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 Sveltes 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 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.”
Headquartered in New
Providence, New Jersey,
Svelte Medical Systems (www.sveltemedical.com) is a privately-held company engaged
in the development of highly deliverable balloon expandable stents. The Svelte
‘All-In-One system represents the first material advance in stent delivery
systems in the last fifteen years and is designed to realize the clinical, time
and cost-savings benefits of direct stenting in a single platform. The company
also plans to commercialize its drug-eluting stent on a conventional
rapid-exchange delivery platform incorporating its proprietary balloon control
band technology.
