Philips Earns FDA Approval for Low-Dose Drug-Coated Balloons

The FDA approved Royal Philips’ two new Stellarex 0.035” low-dose drug-coated balloons for peripheral artery disease patients.

The 150mm and 200mm balloons have the agency’s go-ahead for treating de novo and restenotic narrowing in two upper leg arteries, the native superficial femoral or popliteal arteries.

The approval broadens the available options for physicians treating peripheral artery disease patients with a high risk of recurrent narrowing of an artery previously cleared with a stent or angioplasty.