Stentys Expands Benefits Of First Drug-Eluting, Self-Expanding Stent To Lower Limb Artery Disease

Clinical Trial Found STENTYS Treatment Prevented Amputation in 99% of Cases

PRINCETON, N.J. & PARIS--(BUSINESS WIRE)--STENTYS (Paris:STNT) (FR0010949404 — STNT), a medical technology company commercializing the world’s first and only Self-Apposing^® coronary stent, today announced that its unique Drug-Eluting and Self-Expanding stent was evaluated in 70 patients suffering from critical limb ischemia (CLI) and prevented foot amputation in 99% of them.

“This is the first time we are investigating a drug-eluting self-expanding stent in this setting and the results are extremely promising.”

Artery blockage, which is caused by fatty lesions that impede appropriate blood flow to the organs, can be found in arteries other than the heart, such as in the lower part of the limbs below the knee. The most severe cases, in which tissue of the foot or ankle does not receive enough oxygen supply and begins to die (necrosis), often require amputation. To prevent this outcome, surgeons open up the artery with balloons and implant stents when necessary.

STENTYS initiated early 2012 a single-arm, prospective, multi-center clinical study called “PES BTK-70” that enrolled 70 patients with severe foot wounds due to lack of oxygen (critical limb ischemia or CLI) caused by a blockage in an artery below the knee (BTK). They were all treated with a STENTYS Paclitaxel-eluting Self-Apposing stent. At 12 months follow up, 99% of patients did not require an amputation, 79% did not require a new procedure for that same lesion (freedom from Target-lesion Revascularization) and 73% had an open artery under X-ray (primary patency under corelab-verified angiography).

“Balloons alone have a limited efficacy for BTK lesions and we have yet to find the solution to treat these patients,” said Marc Bosiers, M.D., of Sint-Blasius hospital (Belgium) and Principal Investigator of the trial, who presented the data at the LINC conference. “This is the first time we are investigating a drug-eluting self-expanding stent in this setting and the results are extremely promising.”

“The market to treat below the knee disease, a frequent consequence of diabetes, is growing very fast and our unique product, combining the benefits of self-apposition and drug-elution, could become the new standard of care,” added Gonzague Issenmann, CEO and co-founder of STENTYS. “Once the product is CE Marked, which we expect in the first half of 2015, this indication will represent an opportunity beyond our coronary business for new revenue growth through distribution partners.”

The diabetes global epidemic is projected to translate into a 54% increase in the diabetic population by 2030. Approximately 25% of diabetics suffer from CLI. The global peripheral arterial disease (PAD) market outside of US and Japan is estimated today at $1.3b.

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STENTYS is listed on Comp. B of the NYSE Euronext Paris
ISIN: FR0010949404 – Ticker: STNT

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