Medtronic has won FDA approval to introduce its IN.PACT AV drug-coated balloon as a treatment option for failing arteriovenous (AV) fistulae.
People with non-functional kidneys who undergo dialysis receive AV fistulae, which link an artery to a vein. Veins tend to be too fragile for regular access, but arteries are too deep. Creating an AV fistula makes the connected vein much more resilient and capable of providing vascular access for dialysis.
Eventually, AV fistulae tend to fail because of restenosis, limiting blood flow, and have to be expanded. This is a frequent procedure that comes with dangers, costs, and discomfort. The new Medtronic IN.PACT AV drug-coated balloon is designed to treat restenosis within AV fistulae and to increase the time between such maintenance procedures.
During balloon inflation and structural reconstruction of the fistula, the device releases paclitaxel, an anti-proliferative, into the vessel walls around itself. This slows the process of restenosis and should reduce the number of such procedures that are required.
Some info from Medtronic about the study that led to the approval:
The FDA approval is based on data from a prospective, global, multicenter, blinded, randomized (1:1), investigational device exemption (IDE) study, which enrolled 330 subjects, and evaluated the safety and effectiveness of the IN.PACT AV DCB at 29 sites in the United States, Japan, and New Zealand. Early data presented at the Cardiovascular Interventional Radiological Society of Europe (CIRSE) met the primary endpoints in demonstrating the comparable safety and the superior effectiveness of IN.PACT AV DCB compared to percutaneous transluminal angioplasty (PTA). Patients treated with IN.PACT AV DCB maintained patency longer and required 56% fewer reinterventions compared to those treated with standard PTA through six months. Through 12 months the data also showed no difference in mortality rates between the IN.PACT AV DCB group and the PTA control group. Finally, data presented at VIVA 2019 demonstrated superior patency was achieved with IN.PACT AV DCB versus PTA in both de novo and restenotic lesions, and all studied types of AV access.
Product page: IN.PACT AV