Medtronic (NYSE:MDT) this week said it launched its first drug-coated balloon in Japan for patients undergoing hemodialysis.
The company launched its In.Pact AV drug-coated balloon, which is indicated for the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous dialysis fistulae in patients with end-stage renal disease and undergoing hemodialysis. It is the first drug-coated balloon to be approved in Japan for that vessel bed, according to Medtronic.
In.Pact AV delivers the anti-proliferative drug paclitaxel to the vessel wall by balloon inflation to prevent restenosis and reduce reinterventions. It can maintain AV access site patent to extend the time between reinterventions and maximize a patient’s uninterrupted access to dialysis care.
Patients treated with the drug-coated balloon in a global clinical trial were able to maintain target lesion primary patency longer and required 56% fewer reinterventions to maintain target lesion patency when compared to patients treated with standard percutaneous transluminal angioplasty through six-months.
In.Pact AV received regulatory approval in September 2020 and became eligible for health insurance reimbursement on Feb. 1.
