Medtronic has won FDA approval for its IN.PACT AV drug-coated balloon (DCB) in end-stage renal disease (ESRD) patients, the company said Thursday.
The approval allows Medtronic to sell the paclitaxel-coated balloon as a treatment for failing arteriovenous (AV) access in dialysis patients.
U.S. authorization of the device comes at a time when Medtronic’s broader DCB business is starting to recover from concerns about the safety of paclitaxel-coated devices.
Medtronic demonstrated the potential of its IN.PACT AV DCB in ESRD in September when it posted data from a 330-patient clinical trial. The study linked the device to an improved rate of target lesion patency over percutaneous transluminal angioplasty, meaning patients were able to continue using the same AV fistulae for longer without requiring maintenance procedures.
The data led Medtronic to conclude that IN.PACT AV can free patients from major disruptions in their hemodialysis regimens, potentially resulting in better health outcomes and lower healthcare costs. FDA approved the DCB in the new indication this week. Medtronic received a CE mark for the device in 2016.
In between those two regulatory green lights, the publication of a study linking paclitaxel-coated devices to increased mortality sent shockwaves through the industry. Medtronic reported a drop in DCB sales following the study and subsequent regulatory actions. The situation has improved somewhat recently, with Medtronic reporting a quarter-over-quarter increase in U.S. DCB sales earlier this week.
Talking to investors on a second quarter results conference call, Michael Coyle, the president of Medtronic's cardiac and vascular group, attributed the sequential improvement to the generation of data supportive of the safety of paclitaxel-coated DCBs. The IN.PACT AV study contributed to that shift in the balance of evidence, he said.
"We did not see that mortality signal in the one-year data for those datasets, and we saw very significant reductions in reintervention rates more than 50% reductions in reintervention in that AV fistula patient population, which we think ... is going to help us with the confidence in the [superficial femoral artery] position," Coyle said.
Whatever the impact of the mortality data and access to the new market, Medtronic’s DCB sales figures will likely start looking better in the coming quarters by dint of easier comparisons. Medtronic is now more than one year on from the point at which DCB sales dropped, meaning its upcoming financials will be compared to the lower, post-safety scare figures.