Medtronic presented final study data on the durability of its drug-coated balloon used in angioplasty procedures for patients with peripheral artery disease, in what it described as the first five-year data for a commercially available device of that type.
The company’s IN.PACT Admiral balloon is used to treat PAD in the superficial femoral and popliteal arteries, by releasing paclitaxel chemotherapy into the blood vessel wall to prevent the re-narrowing of the artery due to plaque or the growth of scar tissue.
Presented at the Vascular Interventional Advances annual meeting in Las Vegas, the study showed the Admiral balloon outperforming drugless angioplasty, in keeping patients free from having to undergo subsequent revascularization procedures at the target lesion. In a time-to-event survival analysis, Kaplan-Meier estimates were 74.5% in the drug-coated balloon arm compared to 65.3% in the control group over the five-year follow-up period.
"This is truly remarkable considering the complexity and progressive nature of PAD,” said study co-principal investigator John Laird, medical director of the Adventist Heart and Vascular Institute. “For these patients, it means we are providing them with a long-term, durable solution that reduces the need for frequent reinterventions, leading to a potential improvement in their quality of life.”
In addition, long-term safety benefits included low rates of major limb amputation, at 0.5%, and thrombosis, at 2.2%, with no device or procedure-related deaths through five years in both study arms, according to Medtronic.
"Since the entrance of DCBs into the market several years ago, we have seen a shift towards the use of this technology as a frontline therapy to treat patients with PAD," said Mark Pacyna, VP and general manager of Medtronic’s peripheral artery business. “We believe this new evidence will give physicians the confidence that IN.PACT Admiral DCB is the preferred first line therapy for patients who suffer with femoral-popliteal disease.”
A separate presentation included a pooled, one-year analysis from all of the company’s IN.PACT patients, showing superior freedom from repeat interventions with the Admiral balloon compared to standard angioplasty.
The analysis included 1,837 DCB and 143 angioplasty patients, with 93.8% of Admiral-treated patients avoiding the need for revascularization compared to 80.2% in the control arm. The DCB arm also demonstrated an all-cause mortality rate of 3.1% over one year.