- Concept Medical said Monday it gained FDA breakthrough device designation for its sirolimus-coated balloon for treatment of peripheral artery disease below the knee.
- A clinical trial examining the safety and efficacy of the device, the MagicTouch PTA Sirolimus drug-coated balloon, is in progress for treating below the knee and femoropopliteal lesions.
- The breakthrough designation is the second for Concept, after one granted in April for its sirolimus-coated balloon to treat coronary artery disease in patients with in-stent restenosis. Orchestra BioMed received a similar breakthrough device designation for its sirolimus-eluting balloon for coronary in-stent restenosis.
Treatment of below the knee PAD using paclitaxel-coated devices recently hit a slowdown after a late mortality signal was discovered by researchers and FDA convened an advisory panel that recommended the agency update device labels warning patients of the signal.
If eventually granted marketing authorization by FDA, Concept's sirolimus-coated device may be positioned to pick up market share from medtechs with paclitaxel devices such as BD, Medtronic, Boston Scientific, Philips and Cook Medical.
During BD's earnings call last week, executives announced FDA found its PMA submission for its Lutonix paclitaxel balloon not approvable as submitted.
Breakthrough device designation will enable Concept to more closely interact with FDA reviewers tasked with evaluating the device.
The agency also may "accept a greater extent of uncertainty of the benefit risk-profile for these devices" if they present probable benefits to patients that may gain earlier access to the devices, given there are "adequate postmarket controls to support premarket approval."
Concept hopes its product will help PAD patients avoid amputations resulting from critical limb ischemia.
Sahil Parikh, an interventional cardiologist at Columbia University, said it was a needed product. "Patients with CLI represent an enormous burden to our healthcare system and comprehensive care for these patients begins with effective revascularization," he said in the company's press release.
Parikh has received more than $300,000 in payments for consulting and other services from Abbott, Medtronic and Boston Scientific since 2013.