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Medical Devices

Lutonix 035 Drug Coated Balloon PTA Catheter - P130024

Picture of the device.

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
PMA Applicant: Lutonix
Address: 9409 Science Center Drive, New Hope, MN 55428
Approval Date:  October 9, 2014
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130024a.pdf

What is it? The Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB) uses a drug-coated balloon to re-open blocked or narrowed arteries in the thigh and knee due to peripheral artery disease (PAD). The balloon is coated on its outer surface with the drug paclitaxel; a drug which may help prevent the arteries 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 partially open the blockage or narrowing. The Lutonix DCB is then used to fully open the narrowed portion of the artery and applies the drug to the artery wall.

When is it used? The Lutonix DCB is used when arteries in the thigh and knee are narrowed or blocked as a result of peripheral artery disease. PAD occurs when fatty material (plaque) builds up in these arteries, which can cause hardening and/or narrowing of the arteries (atherosclerosis), limiting the flow of oxygen-rich blood to the body. People with PAD may experience lifestyle-limiting symptoms, such as leg pain, or serious complications, including skin ulcers or gangrene.

What will it accomplish? The Lutonix drug-coated balloon will open up a narrow or blocked artery in the thigh and knee.

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

  • Patients who cannot take recommended medicines that thin the blood and prevent blood clots.
  • Patients with a known hypersensitivity to paclitaxel or drugs with similar characteristics as paclitaxel.
  • Women who are breastfeeding, pregnant or intend to become pregnant; or men intending to father children. It is unknown whether paclitaxel will be excreted in human milk and there is a potential for adverse reactions in nursing infants from paclitaxel exposure.
  • Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system.

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

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Page Last Updated: 01/11/2016
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