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 AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
PMA Applicant: Medtronic, Inc.
Address: 3576 Unocal Place, Santa Rosa, CA 95403
Approval Date: November 21, 2019
Approval Letter: Approval Order
What is it? The IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (IN.PACT AV DCB) is a PTA balloon catheter that uses a drug-coated balloon to open a blocked or narrowed arteriovenous (AV) fistula. An AV fistula is a surgically created connection between an artery and vein used as an access site for hemodialysis treatment (removing waste from the blood of patients with kidney failure). The balloon is coated on its outer surface with the drug paclitaxel, a drug which may help prevent the vessel from narrowing again (restenosis).
How does it work? The blood vessel is prepared with an uncoated balloon catheter that is inflated to partially open the blockage or narrowing.The IN.PACT AV DCB is then used to fully open the narrowed portion of the AV fistula and apply the drug to the vessel wall.
When is it used? The IN.PACT AV DCB is used when an AV fistula is narrowed or blocked. Narrowing of an AV fistula can cause blood flow to slow down and reduce the effectiveness of dialysis.
What will it accomplish? The IN.PACT AV DCB is intended to open up a narrowed or blocked AV fistula. This device was shown to be as safe and effective as standard angioplasty balloons with no drug coating. At 30 days, the IN.PACT AV DCB was as safe as standard balloon angioplasty (4.2% vs 4.4%, Serious Adverse Event (SAE) rate involving the AV fistula access circuit) and at 6 months, was able to keep open 82.2% of AV fistulas compared to 59.5% with standard balloon angioplasty.
When should it not be used? The IN.PACT AV DCB should not be used in:
- Coronary arteries, renal arteries, and supra-aortic/cerebrovascular arteries
- Patients who cannot receive 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 known allergies or sensitivities to paclitaxel or drugs with similar charteristics as paclitaxel.
- Women who are breastfeeding, pregnant, or intend to become pregnant, or men intending to father children.
Additional information (including warnings, precautions, and adverse events):