The study results were presented at the Cardiovascular and Interventional Radiology Society of Europe (CIRSE) annual meeting in Barcelona, Spain
Medtronic has announced the results from the clinical study of its investigational IN.PACT AV drug-coated balloon (DCB) for treating restenotic arteriovenous (AV) fistulae lesions.
The clinical study compared the IN.PACT AV DCB with percutaneous transluminal angioplasty (PTA) and has reached the primary safety and effectiveness endpoints.
Auckland Hospital director and associate professor of radiology Andrew Holden said: “Maintaining patency and limiting the frequency of reinterventions needed to keep AV access sites functioning properly remain significant treatment challenges for physicians treating AV fistulae lesions.
“These results demonstrate the promise of IN.PACT AV DCB to not only address these critical issues, but to potentially improve the quality of life of patients undergoing dialysis.”
AV fistulae, dubbed AV access sites, are used for patients with end-stage renal disease (ESRD) to deliver hemodialysis, as vessel restenosis limits the use of AV fistulae over time.
To restore the function, patients are subjected to AV fistula maintenance procedures, while frequent reinterventions can result in significant disruptions to critical hemodialysis care and increased costs to the healthcare system.
Drug-coated balloons maintain AV access site patency, and are capable of extending the time between reinterventions to maximise patient’s access to lifesaving dialysis care.
The IN.PACT AV DCB is an investigational device and not yet approved for commercial use in the US
Medtronic said that the IN.PACT AV Access study is a randomised controlled trial (RCT), enrolled 330 subjects at 29 sites across the US, Japan, and New Zealand.
The freedom from clinically-driven target lesion revascularisation (CD-TLR) or access circuit thrombosis measured through six months post-procedure was set as the primary effectiveness endpoint of the study, and the serious adverse event rate involving the AV Access circuit through 30 days post-procedure was the primary safety endpoint.
In addition, the access circuit primary patency, cumulative target lesion revascularisations, and number of interventions required maintaining target lesion patency are among the other endpoints.
Medtronic peripheral vascular business vice president and general manager Mark Pacyna said: “The data presented today at CIRSE demonstrate the potential of IN.PACT AV DCB to address restenosis in high-risk patients who currently have few long-term treatment options available to them.
“As part of our commitment to improving outcomes, we look forward to generating further clinical evidence in support of this therapy.”