Concept Medical has been granted breakthrough device designation from the US Food and Drug Administration (FDA) for its MagicTouch percutaneous transluminal angioplasty (PTA) sirolimus drug-coated balloon (DCB) catheter, used in the treatment of peripheral arterial disease (PAD) in infra-popliteal lesions. The first breakthrough device designation received by Concept Medical was on 30 April 2019 for its MagicTouch sirolimus-coated balloon, for the treatment of coronary arterial disease (CAD) in patients with in-stent restenosis.
Concept Medical has pioneered the sirolimus drug delivery platform technology (Nanolute Technology) which has been used in more than 30,000 patients worldwide. The MagicTouch PTA sirolimus-coated balloon is developed using this Nanolute Technology for use in PAD.
In an ongoing clinical study (XTOSI), associate professor Edward Choke, principal investigator of the trial and chief of Vascular Surgery, Sengkang General Hospital, Singapore, said, “XTOSI study is the world’s first pilot study to investigate the safety and efficacy of novel MagicTouch PTA sirolimus drug-coated balloon in the treatment of below the knee 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 ischaemia (more than 90% had the most severe Rutherford scores of 5 or 6). The extent of peripheral arterial disease treated were 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 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 six months, freedom from clinically driven target lesion revascularisation (TLR) 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 sirolimus-coated balloon in below the knee vessels.”
Sahil Parikh, an interventional cardiologist and associate professor of Medicine and director of Endovascular Services at the Columbia University College of Physicians and Surgeons (New York, USA) says, “The breakthrough designation demonstrates how important it is for us to have new technologies for below the knee intervention. Patients with critical limb ischemia (CLI) represent an enormous burden to our healthcare system and comprehensive care for these patients begins with effective revascularisation. The MagicTouch PTA will hopefully bring us closer to our goals of reducing amputations in the USA and the world.”
According to a press release, this breakthrough device offers Concept Medical an opportunity to interact with the FDA’s experts through several different programme options “to efficiently address topics as they arise during the premarket review phase, which can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way”. Manufacturers can also expect prioritised review of their submission. Under the programme, the FDA will provide Concept Medical with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialisation decisions.
