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  1. Device Approvals, Denials and Clearances

Medtronic IN.PACT™ Admiral™ Paclitaxel-Coated PTA Balloon Catheter - P140010/S037

Image 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: IN.PACT™ Admiral™ Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
PMA Applicant: Medtronic, Inc.
Address: 3576 Unocal Place, Santa Rosa, CA 95403
Approval Date: April 19, 2018
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140010S037a.pdf

What is it? The Medtronic IN.PACT Admiral Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (Medtronic DCB) uses a drug-coated balloon to re-open blocked or narrowed arteries in the thigh and knee due to peripheral artery disease (PAD). This device can be used to prevent re-narrowing within a stent placed previously to open the blood vessel or to treat long blockages. The balloon is coated on its outer surface with the drug paclitaxel, which may help prevent the arteries from narrowing again (restenosis).

How does it work? The blood vessel is prepared with another device in order to partially open the blockage or narrowing. The Medtronic 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 Medtronic 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 Medtronic drug-coated balloon will open up a narrow or blocked artery in the thigh and knee, including long blockages. A clinical study showed favorable outcomes for patients with long blockages, with results demonstrating trends towards decreased need for additional procedures to open their artery for the 12 months following treatment with the Medtronic DCB.

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

  • Patients who have narrowed arteries in the heart, kidneys, or brain.
  • Patients who cannot take recommended medicines that thin the blood and prevent blood clots.
  • Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system.
  • 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.

Additional information (including warnings, precautions, and adverse events): The Summary of Safety and Effectiveness Data and labeling are available online.