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Medical Devices / Submissions and Approvals

FDA Clears Drug Coated Catheter for Marketing

Nov. 22, 2017

The FDA has approved the Lutonix 035 drug coated balloon percutaneous transluminal angioplasty catheter, Model 9010 for commercial distribution with certain restrictions.

The device is a thin tube with an inflatable balloon at the tip used to treat narrowed or blocked blood vessels. It is used as an access site for dialysis in patients with chronic kidney failure.

The balloon is coated on its outer surface with the drug paclitaxel to help prevent the vessels from narrowing again.

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