Medtronic (NYSE:MDT) touted data today from a two-year study of its In.Pact Admiral drug-coated balloon in patients with peripheral artery disease in Japan, as well as the results from a critical limb ischemia subgroup analysis from its In.Pact Global trial.
The company’s In.Pact SFA Japan study enrolled 100 patients and randomized them to receive either the drug-coated balloon or plain balloon angioplasty.
The group treated with the drug-device combo had a 79.8% primary patency rate, compared to 46.9% for those in the PTA group after two years. Also, Medtronic reported that the DCB group had a clinically-driven target lesion revascularization rate of just 9.1%, much lower than the 20.7% rate seen in the PTA group. The rate of major adverse events was much lower for the DCB group after two years, as well.
“Across SFA trials, In.Pact Admiral has consistently demonstrated superior safety and efficacy compared to PTA,” Dr. Osamu Iida, of the Kansai Rosai Hospital, said in prepared remarks. “We are pleased to see comparable results in Japan at two-years with durable patency outcomes, low TLR, and no instances of thrombosis. There has been a critical unmet need in Japan for new technologies that safely and effectively treat PAD, and we believe IN.PACT Admiral is well-positioned to meet this need.”
In September, Medtronic’s In.Pact Admiral won approval from the Japanese Ministry of Health, Labor and Welfare for the treatment of peripheral artery disease in the upper leg. The company later landed reimbursement approval for the device and is gearing up to commercially launch its product in Japan.
In a critical limb ischemia cohort of the In.Pact Global study, Medtronic’s drug-coated balloon showed consistent treatment effect among 156 patients with Rutherford Classification Categories four and five. Both groups had comparable rates of freedom from clinically-driven target lesion revascularization and the rate of of major target limb amputations was just 1.4%.
“The treatment of CLI in PAD remains a challenge and has led to the need for more clinical evidence around the safety and efficacy of DCB in this population,” Dr. Michel Reijnen, a vascular surgeon at Rijnstate Hospital in the Netherlands, said in a statement. “The data presented today are very encouraging in that we were able to confirm In.Pact Admiral’s strong performance in this clinically complex patient subset, as well as improved quality of life.”
“Our investment in clinical data is coupled with a commitment to working with the clinical community to provide timely access to new data that gives clinicians the information they need to determine treatment options for patients with this complex and chronic disease,” Mark Pacyna, VP & GM of Medtronic’s peripheral business, added.
“The Japan two-year data presented today builds upon our global clinical data sets and shows that In.Pact Admiral continues to be a durable, safe and effective option for the treatment of PAD. Additionally, the CLI analysis builds upon our growing body of evidence that demonstrates In.Pact Admiral is effective in more complex patients. We look forward to continued opportunities to bring this therapy to more patients around the world.”