FDA approves Lutonix 035 DCB balloon catheter for treatment of Peripheral Artery Disease- Lutonix Inc.
The FDA on 10 October 2014 approved the Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB) from Lutonix Inc. This is the first drug-coated balloon used to re-open arteries in the thigh (superficial femoral arteries) and knee (popliteal arteries) when narrowed or blocked as a result of Peripheral Artery Disease (PAD).
As part of the approval, the FDA is requiring the manufacturer to conduct two post-approval studies. One is a five-year post-approval study of 657 patients treated with the Lutonix DCB to further monitor safety and effectiveness. The second is a randomized, single blind, multi-center study which will assess the safety and effectiveness of the Lutonix DCB in women in the United States, due to differences in observed outcomes in this group as compared to outcomes for the general study population.
CE Mark was granted for the Lutonix 035 DCB in Europe in 2012.
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