Medtronic’s In.Pact AV DCB Launched in Japan

March 3, 2021—Medtronic announced the launch of the In.Pact AV drug-coated balloon (DCB) in Japan. The device is indicated for the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous (AV) dialysis fistula in patients with end-stage renal disease undergoing hemodialysis.

The company advised that the In.Pact AV DCB received regulatory approval in Japan on September 23, 2020, and it became eligible for health insurance reimbursement on February 1, 2021.

According to Medtronic, the In.Pact AV DCB delivers paclitaxel to the vessel wall by balloon inflation to prevent restenosis and reduce reinterventions. The device has the potential to maintain AV access site patency, which can extend the time between reinterventions, therefore maximizing a patient’s uninterrupted access to dialysis care.

In August 2020, Medtronic announced that the primary endpoint results from the IN.PACT AV Access randomized controlled trial of the In.Pact AV DCB were published by Robert A. Lookstein, MD, et al in The New England Journal of Medicine (2020;383:733-742). In this global clinical trial, patients treated with In.Pact AV DCB maintained target lesion primary patency longer and required 56% fewer reinterventions to maintain target lesion patency as compared to those treated with standard percutaneous transluminal angioplasty through 6 months, noted the company.