Presentations Support Medtronic's In.Pact Admiral Drug-Coated Balloon
January 30, 2018—Medtronic announced that clinical data supporting the company's In.Pact Admiral drug-coated balloon (DCB) were presented at LINC 2018: the Leipzig Interventional Course held January 30 to February 2 in Leipzig, Germany. The presentations included the 2-year results from the MDT-2113 study (IN.PACT SFA Japan) and data from a critical limb ischemia (CLI) subgroup analysis from the IN.PACT Global Study.
Osamu Iida, MD, presented the new data from the IN.PACT SFA Japan study, which enrolled 100 patients across 11 sites in Japan and randomized treatment to either DCB (n = 68) or plain balloon percutaneous transluminal angioplasty (PTA; n = 32). The results were consistent with 2-year findings from the pivotal IN.PACT SFA Study, showing a low clinically driven target lesion revascularization (CD-TLR) rate and high patency rate, stated Medtronic.
In the IN.PACT Admiral SFA Japan study, primary patency was 79.8% in the DCB group as compared to 46.9% in the PTA group at 2 years based on Kaplan-Meier estimate (P < .001). The CD-TLR rate was 9.1% for the DCB group compared to 20.7% in the PTA group (P = .177), and freedom from CD-TLR based on Kaplan-Meier estimate was 90.8% for the DCB group compared to 81.3% in the PTA group (P = .114).
Additionally, major adverse events were lower for the DCB group at 2 years compared to the PTA group (15.2% vs 24.1%; P = .384), with no major target limb amputations. There were no additional safety concerns at 2 years.
In the company's announcement, Dr. Iida commented, "Across SFA trials, In.Pact Admiral has consistently demonstrated superior safety and efficacy compared to PTA. We are pleased to see comparable results in Japan at 2 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 peripheral artery disease (PAD), and we believe In.Pact Admiral is well-positioned to meet this need."
In September 2017, the company announced Japanese Ministry of Health, Labor and Welfare (MHLW) approval of In.Pact Admiral for the treatment of PAD in the superficial femoral and popliteal arteries. In December, the MHLW granted reimbursement approval for In.Pact Admiral. The company expects to launch In.Pact Admiral in Japan after completing the conditions associated with Shonin approval, advised Medtronic.
The 1-year results from the CLI subset of the IN.PACT Global Study were presented at LINC by Michel Reijnen, MD. The subset included data from 156 patients with Rutherford class 4 and 5 disease, with the In.Pact Admiral demonstrating a consistent treatment effect among these patients.
Data showed comparable effectiveness, with a freedom from CD-TLR based on Kaplan-Meier estimate of 86.6% for Rutherford class 4 and 85.5% for Rutherford class 5 (P = .6881) and an overall low rate (1.4%) of major target limb amputations. Additionally, treatment with the In.Pact Admiral improved quality of life as measured by the EuroQoL five dimensions from baseline to 12 months (P < .001).
Dr. Reijnen commented in the company's announcement, "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. 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."