Concept Medical Inc. announced that it has been granted Breakthrough Device Designation (BDD) from the FDA for its MagicTouch percutaneous transluminal angioplasty (PTA) sirolimus-coated balloon (SCB) catheter for the treatment of peripheral artery disease (PAD) below the knee (BTK).
Under the BDD program, the FDA will provide the company with priority review and interactive communication regarding device development and clinical trial protocols through to commercialization decisions.
The principal investigator of the ongoing XTOSI clinical study is Edward Choke, MD, Associate Professor and Chief of Vascular Surgery, Sengkang General Hospital in Singapore. Dr. Choke stated in the company's press release, “[The] study is the world’s first pilot study to investigate the safety and efficacy of novel MagicTouch PTA SCB in the treatment of BTK arterial lesions in addition to femoropopliteal lesions. 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). The extent of PAD treated were also severe, and about 80% of patients did not have any patent BTK arteries before angioplasty."
Dr. Choke continued, "I am very encouraged by the excellent results so far in these 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 6 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.”
Sahil Parikh, MD, added, “The breakthrough designation demonstrates how important it is for us to have new technologies for BTK intervention. Patients with critical limb ischemia represent an enormous burden to our health care system and comprehensive care for these patients begins with effective revascularization. The MagicTouch PTA will hopefully bring us closer to our goals of reducing amputations in the US and the world.” Dr. Parikh, an interventional cardiologist, is Associate Professor of Medicine and Director of Endovascular Services at the Columbia University College of Physicians and Surgeons in New York, New York.
The company noted that its first BDD was granted in April for the MagicTouch SCB for the treatment of coronary artery disease in patients with in-stent restenosis. The MagicTouch DCB has received European CE Mark approval and is commercially available in those countries that recognize CE Mark. The MagicTouch PTA for PAD treatment incorporates Concept Medical's nanolute technology for the sirolimus delivery platform, which has been used in coronary applications in more than 30,000 patients.
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