Lutonix 035 Drug Coated Balloon PTA Catheter regulatory update

FDA approved a PMA from C.R. Bard for Lutonix 035 Drug Coated Balloon PTA Catheter for percutaneous transluminal angioplasty, after pre-dilation, of de novo or restenotic lesions up to 150 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. The company said the product is the first drug-coated balloon catheter in the U.S. and that it is already available in the country. Lutonix 035 is in U.S. trials to treat below the knee arteries and in-stent restenosis (ISR). In 2Q15, the company plans to start 2 postmarketing safety studies of Lutonix 035. ...