Medtronic (NYSE:MDT) today touted five-year data for its In.Pact Admiral drug-coated balloon, highlighting the durability and efficacy of its device in people with peripheral artery disease in the superficial femoral and popliteal arteries.
The company presented five-year results from its pivotal In.Pact SFA trial at the 2018 Vascular Interventional Advances conference.
“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,” Mark Pacyna, VP & GM of Medtronic’s peripheral business, said in prepared remarks.
“This is especially true of In.Pact Admiral DCB, which has consistently proven to be one of the safest, most effective, and durable therapies in treating patients across the spectrum of femoral-popliteal disease. We are proud to have become the first company to share five-year data on a commercially-available DCB and the first to present outcomes from the largest pooled analysis in the peripheral space to-date,” Pacyna added.
In the In.Pact SFA trial, Medtronic’s drug-coated balloon continued to outperform the percutaneous transluminal angioplasty control group in freedom from clinically-driven target lesion revascularization over five years.
People who were treated with the In.Pact Admiral device also had low rates of major target limb amputation (0.5%) and thrombosis (2.2%).
“With the data presented today at VIVA, we continue to see sustained clinical benefit of In.Pact Admiral with three quarters of DCB patients in the study not requiring a reintervention through five years,” co-principal investigator Dr. John Laird said. “This is truly remarkable considering the complexity and progressive nature of PAD. 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.”