Stentys’ drug-eluting and self-expanding stent was evaluated in 70 patients suffering from critical limb ischemia and prevented foot amputation in 99% of them.
In early 2012, Stentys initiated a single-arm, prospective, multicentre clinical study called “PES BTK-70” that enrolled 70 patients with critical limb ischemia caused by a blockage in an artery below the knee. 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 revascularisation) and 73% had an open artery under X-ray (primary patency under corelab-verified angiography).
“Balloons alone have a limited efficacy for below the knee lesions and we have yet to find the solution to treat these patients,” said Marc Bosiers 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, chief executive officer 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 critical limb ischaemia. The global peripheral arterial disease market outside of USA and Japan is estimated today at US$1.3bn.