French stent company STENTYS, best known for its world-first and indeed only Self-Apposing® coronary stent, is branching out into peripheral vascular territory. The company tells us 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.
It’s pretty clear that if you make stents you might as well make them for all indications, but in the case of Stentys it looks like the company has decided to deliberately tap into the global diabetes epidemic, which brings with it a glut of peripheral arterial disease (PAD). With the diabetic population projected to increase by 54% by 2030, and with approximately 25% of diabetics suffering from CLI, the market, estimated globally at $1.3b is not about to decrease.
Back in early 2012 Stentys initiated 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 (so-termed 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.”
Source: Business Wire