Lutonix 035, First Drug Coated Balloon Catheter Approved by FDA
 

Lutonix 035, First Drug Coated Balloon Catheter Approved by FDA
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C. R. Bard an**unced that its Lutonix 035 Drug Coated Balloon (DCB) Catheter received FDA approval and is being made available in the U.S. According to the company, the device is intended for “percutaneous transluminal angioplasty (PTA), after pre-dilatation, for the treatment of de **vo or reste**tic lesions up to 150mm in length in native vascular disease of the superficial femoral or popliteal arteries with reference vessel diameters of 4-6mm.”

This is the first drug coated (paclitaxel) balloon catheter approved in the U.S.*and it’s*been available in the European market since 2012.

From the an**uncement:

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FDA approval of the Lutonix® 035 DCB was supported by results of the LEVANT 2 pivotal study, a global, prospective, single-blind, randomized, 54-site study (42 sites in the U.S. and 12 in Europe) that enrolled all patients under one protocol. At one year, the LEVANT 2 study demonstrated improved patency of the Lutonix® 035 DCB compared to standard PTA: 73.5 percent vs. 56.8 percent, p