Medtronic has reported positive data from a clinical study that assessed its IN.PACT AV drug-coated balloon (DCB) to treat de novo or non-stented restenotic arteriovenous (AV) fistulae lesions in patients with end-stage renal disease (ESRD).
The investigational device met the primary safety and effectiveness endpoints in comparison with percutaneous transluminal angioplasty (PTA).
In ESRD patients, the administration of haemodialysis is through AV fistulae. However, the use of the fistulae is limited due to vessel restenosis over time, with patients requiring additional procedures, which could interrupt haemodialysis.
DCBs are intended to maintain AV access site patency and to extend the duration between re-interventions, increasing the period of uninterrupted access to dialysis.
Medtronic’s randomised controlled study, IN.PACT AV Access included 330 patients who had been on dialysis for an average of 4.3 years. It took place at 29 sites across the US, Japan and New Zealand.
The primary safety endpoint of the study was the serious adverse event rate associated with the AV Access circuit over 30 days following the procedure.
Meanwhile, the primary effectiveness endpoint was freedom from clinically-driven target lesion revascularisation (CD-TLR) or access circuit thrombosis through six months after the procedure.
Results showed clinical benefit with the company’s DCB versus the PTA control.
At 180 days, the primary patency rate of the target lesion was 86.1% with the IN.PACT AV DCB compared to 68.9% in the control arm. The figure was 81.4% versus 59% at 210 days.
Participants treated with the DCB were found to need 56% fewer re-interventions for maintaining target lesion patency over 210 days.
The rate of access circuit-related serious adverse events was 4.2% in the DCB arm, while it was 4.4% with the PTA, through 30 days.
Furthermore, the freedom from all-cause death was 90.6% versus 90.4% over 360 days.
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.”
The IN.PACT Admiral DCB received the European CE-Mark in January 2016 to treat failing arteriovenous access in ESRD patients on dialysis.