March 4, 2021 — Medtronic 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 100 mm in length in the native arteriovenous (AV) dialysis fistulae in patients with end-stage renal disease (ESRD) undergoing hemodialysis. It is the first drug-coated balloon to be approved in Japan for this vessel bed. In Japan, IN.PACT AV DCB received regulatory approval on September 23, 2020 and it became eligible for health insurance reimbursement on February 1, 2021.
About 340,000 patients undergo dialysis in Japan, and about 97% of them (about 330,000 patients) receive hemodialysis[i]. Many of these patients need an AV fistulae in order to receive continuous hemodialysis. AV fistulae serve as lifelines for hemodialysis patients and maintaining access to these sites is essential. However, vessels that feed the access site can narrow over time, and some patients become unable to receive sufficient hemodialysis because of failing AV access. They undergo intravascular procedures in order to restore function, some of whom require frequent reinterventions.
The IN.PACT AV DCB delivers the antiproliferative drug paclitaxel to the vessel wall by balloon inflation to prevent restenosis and reduce reinterventions.The IN.PACT AV DCB 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 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)[ii] through six months.
[i] 2018 Annual Dialysis Data Report, JSDT Renal Data Registry. The Japanese Society for Dialysis Therapy.
[ii] Lookstein RA, Haruguchi H, Ouriel K, et al. Drug-Coated Balloons for Dysfunctional Dialysis Arteriovenous Fistulas. N Engl J Med. 2020;383(8):733-742. doi:10.1056/NEJMoa1914617