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 The leading web portal for pharmacy resources, news, education and careers November 18, 2017
Pharmacy Choice - Pharmaceutical News - C. R. Bard Receives FDA Premarket Approval of the LUTONIX 035 Drug Coated Balloon as the First and Only DCB for the Treatment of Patients with... - November 18, 2017

Pharmacy News Article

 9/11/17 - C. R. Bard Receives FDA Premarket Approval of the LUTONIX 035 Drug Coated Balloon as the First and Only DCB for the Treatment of Patients with...

C. R. Bard Receives FDA Premarket Approval of the LUTONIX 035 Drug Coated Balloon as the First and Only DCB for the Treatment of Patients with Dysfunctional AV Fistulae

By a News Reporter-Staff News Editor at Clinical Trials Week C. R. Bard, Inc. (NYSE:BCR) announced the LUTONIX 035 Drug Coated Balloon PTA Catheter (DCB) has been granted premarket approval (PMA) by the U.S. Food and Drug Administration (FDA) for a new indication and is now available for sale in the United States. With this approval, the LUTONIX 035 DCB Catheter becomes the first and only drug coated balloon that is FDA approved as safe and effective in end stage renal disease (ESRD) patients with stenotic lesions in dialysis arteriovenous (AV) fistulae. This latest approval adds to the prior FDA indication of the LUTONIX 035 DCB Catheter for the treatment of superficial femoral artery (SFA) and popliteal artery disease (see also C. R. Bard, Inc.).

The FDA approval was based on the results of the LUTONIX AV Clinical Trial, the first investigational device exemption (IDE) trial using drug coated balloons in patients with stenotic lesions in AV fistulae. The follow-up results from randomized patients who were treated with the LUTONIX 035 DCB Catheter demonstrated safety comparable to uncoated balloons.

Keywords for this news article include: Angiology, C. R. Bard Inc., Government Agencies Offices and Entities.

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2017, NewsRx LLC



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