Medtronic has announced the launch of IN.PACT AV drug-coated balloon (DCB) in Japan. IN.PACT AV DCB is indicated for the treatment of obstructive lesions up to 100mm in length in the native arteriovenous (AV) dialysis fistulae in patients with end-stage renal disease (ESRD) undergoing haemodialysis. It is the first DCB to be approved in Japan for this vessel bed.
In Japan, IN.PACT AV DCB received regulatory approval on 23 September 2020 and it became eligible for health insurance reimbursement on 1 February 2021.
According to a press release, IN.PACT AV DCB has the potential to maintain AV access site patency, which can extend the time between reinterventions, therefore maximising a patient’s uninterrupted access to dialysis care has been needed.
In a 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 (PTA) through six months.