Svelte® Medical Systems today announced completion of enrollment in the
DIRECT (Direct Implantation
of Rapamycin-eluting stent with bio-Eroding
study conducted at four investigational sites in 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-absorbable drug
carrier and the well-studied sirolimus (rapamycin) drug mounted on a
fixed-wire Integrated Delivery System (IDS). The 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 from conventional stenting
procedures, thereby reducing procedure time and cost.
"The Svelte system proved highly deliverable across a range of coronary
lesions, including some which were rather challenging for a
first-in-human study. The unique delivery system and bioabsorbable drug
carrier, coupled with a proven drug compound, make for a truly novel
drug-eluting stent platform. We look forward to sharing the robust
30-day clinical outcomes from the DIRECT study," said Mark Webster,
MBChB, an interventional cardiologist at Auckland City Hospital and
principal investigator for the DIRECT study. Interim analysis and case
studies from the DIRECT study will be presented by Dr. Webster at the
EuroPCR course in Paris, France May 15-18.
The Svelte drug-eluting stent system is designed to couple the benefits
of procedural time and cost savings realized through an IDS with the low
restenosis rates associated with the latest generation drug-eluting
stents. The non-inflammatory and non-thrombogenic bioabsorbable drug
carrier further offers the potential to positively impact patient safety
and reduce long-term needs for dual anti-platelet therapy.
"Completing enrollment in the DIRECT study represents an important
accomplishment for our company. We will continue working diligently to
demonstrate the clinical and economic benefits our system provides
patients, physicians and payers, and sincerely thank the DIRECT study
investigators and their teams for their efforts on behalf of the study,"
said Mark Pomeranz, President and CEO of Svelte Medical Systems.
Data from Europe demonstrate the Svelte IDS significantly reduces
radiation exposure, contrast use, adjunctive interventional product use
and overall procedure time when compared with conventional stent
systems. The Svelte IDS utilizing a bare metal stent platform received
CE Mark certification in August of 2010 and is commercially available in
select European and Latin American markets. The company expects to
initiate a European-based clinical study in support of CE Mark
certification for its drug-eluting stent platform later this year and
plans to offer both an IDS and conventional rapid-exchange delivery
platform incorporating its proprietary Balloon Control Band (BCB)
technology upon commercial release.
Source: Svelte Medical Systems