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Lutonix® 035 Drug Coated Balloon PTA Catheter, Model 9010 - P170003

Image of the device, illustrating drug coating, radiopaque marker bands, shaft length, inflation luer, and guidewire luer.

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: Lutonix® 035 Drug Coated Balloon PTA Catheter, Model 9010
PMA Applicant: Lutonix, Inc.
Address: 9409 Science Center Drive, New Hope, MN 55428
Approval Date: August 25, 2017
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170003a.pdf

What is it? The Lutonix® 035 Drug Coated Balloon PTA Catheter (Lutonix 035 DCB) is a thin tube with an inflatable balloon at the tip. The device is used to treat narrowed or blocked blood vessels 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, a drug which may help prevent the vessels from narrowing again (restenosis).

How does it work? A traditional angioplasty balloon catheter is inserted through the blood vessels, across the blockage or narrowing, and inflated to initially open the blockage or narrowing. This catheter is removed and the Lutonix 035 DCB is inserted to the same location and inflated to fully open the blood vessel while at the same time applying the drug to the vessel wall. After several minutes, the Lutonix 035 DCB is removed.

When is it used? In dialysis patients, a surgical connection is created between the artery and the vein that is used as an access site (AV fistula). The Lutonix 035 DCB is used when the AV fistula is narrowed or blocked, which can cause blood flow to slow down and reduce the effectiveness of dialysis.

What will it accomplish? The Lutonix 035 DCB will open a narrowed or blocked AV fistula. In a clinical study of 285 patients, this device was shown to be as safe as a standard balloon catheter without a drug coating. In addition, at six months after treatment, the Lutonix 035 DCB was able to keep open about 7 out of 10 AV fistulas treated as compared to about 6 out of 10 with standard balloon angioplasty.

When should it not be used? The Lutonix 035 DCB should not be used in:

  • Women who are breastfeeding, pregnant or intend to become pregnant; or men intending to father children over the next 2 years. It is unknown whether paclitaxel will be excreted in human milk and if there is a potential for adverse reactions in nursing infants from paclitaxel exposure.
  • Patients judged to have a lesion that prevents complete inflation of a balloon catheter or proper placement of the delivery system.

Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.