Medtech developer Concept Medical said today it won FDA breakthrough device designation for below-the-knee (BTK) use of its MagicTouch sirolimus drug-coated balloon catheter designed for the treatment of peripheral artery disease.
The Tampa, Fla.-based company won the same designation for MagicTouch for the treatment of coronary in-stent restenosis in April.
The XTOSI clinical study at Sengkang General Hospital in Singapore is the world’s first pilot study to investigate the safety and efficacy of novel MagicTouch PTA Sirolimus drug-coated balloon (SCB) in the treatment of below-the-knee arterial lesions in addition to femoropopliteal lesions, according to principal investigator and chief of vascular surgery Edward Choke.
“The majority of patients enrolled had major comorbidities (diabetes and end-stage renal failure) and the indication for angioplasty was for severe critical limb ischemia (more than 90% had the most severe Rutherford scores of 5 or 6),” Choke said in a news release. “The extent of peripheral arterial disease treated was also severe, and about 80% of patients did not have any patent below-the-knee arteries before angioplasty.
“I am very encouraged by the excellent results so far in (this) challenging cohort of patients. Device and technical success were both 100%. Freedom from device- and procedure-related mortality was 100%. Limb salvage rate at 30 days was 97%. At six months, freedom from clinically-driven target lesion revascularization was 91%; and primary patency, independently and blindly assessed by duplex ultrasound, was 82%. I did not encounter any distal embolization or ‘slow-flow phenomenon’ after application of SCB in BTK vessels.”
The breakthrough designation demonstrates the importance of having new technologies for BTK intervention, according to Dr. Sahil Parikh, an interventional cardiologist and director of endovascular services at the Columbia University College of Physicians and Surgeons.
“Patients with (critical limb ischemia) represent an enormous burden to our healthcare system and comprehensive care for these patients begins with effective revascularization,” Parikh said. “The MagicTouch PTA will hopefully bring us closer to our goals of reducing amputations in the U.S. and the world.”