FDA Grants Pre-Market Approval to Spectranetics’ Drug-Coated Balloon

Spectranetics secured FDA pre-market approval for its Stellarex drug-coated balloon.

The device, aimed at returning blood flow to the femoral and popliteal arteries, went through five randomized trials. The device proved safe and effective during the trials and demonstrated low rates of legion revascularization, the company said.

Spectranetics touted the clinical trial data in combination with a cohort of patients studied in a European controlled trial as proof of the device’s efficacy in addressing femoropopliteal disease in diverse populations.