New Data Presented for Medtronic's In.Pact Admiral Drug-Coated Balloon

September 19, 2016—Medtronic plc announced that 3-year results from the pivotal IN.PACT SFA Trial and 1-year, real-world results from the full clinical cohort of the IN.PACT Global Study were revealed in late-breaking clinical trial presentations at VIVA 16, the Vascular InterVentional Advances annual conference in Las Vegas, Nevada. The data from the studies reinforced the durability, consistency, and safety of the In.Pact Admiral drug-coated balloon (DCB) in patients with peripheral artery disease (PAD) in the superficial femoral artery (SFA) or proximal popliteal artery (PPA), stated the company.

Prakash Krishnan, MD, presented the 3-year outcomes from the IN.PACT SFA Trial that demonstrated the sustained, long-term clinical benefits of the In.Pact Admiral DCB compared to percutaneous transluminal angioplasty (PTA).

In Medtronic’s announcement, Dr. Krishnan stated, “The In.Pact Admiral is the only DCB to-date with superior performance supported by 3-year data. In line with the 1- and 2-year data, we saw a consistently low clinically driven target lesion revascularization rate and high patency rate. These durable, long-term outcomes reinforce the shift we are seeing in adoption of In.Pact Admiral DCB as the primary option for treatment.” Dr. Krishnan is Assistant Professor of Medicine and Director of Endovascular Intervention at Mount Sinai Heart in New York, New York.
 
As summarized in Medtronic’s press release, the IN.PACT SFA Trial enrolled 331 patients at 57 sites across Europe and the United States. The patients were randomized to treatment with either the In.Pact Admiral DCB or PTA. The data demonstrate strong durability through 3 years with superior performance in both primary patency for In.Pact Admiral DCB versus PTA (69.5% vs 45.1%; P < .001) and clinically driven target lesion revascularization (CD-TLR) (15.2% vs 31.1%; P = .002). In addition, of the patients who received a repeat procedure within 3 years, those in the In.Pact Admiral DCB group did not require a second procedure as soon as those in the PTA group (542.9 days vs 302.9 days; P < .001). The data also continue to demonstrate the long-term safety benefits, with no major target limb amputations in the IN.PACT Admiral DCB group.

In a separate session at VIVA 2016, the new 1-year results from the full clinical cohort of the IN.PACT Global Study continue to underscore the consistent performance in both safety and efficacy for the In.Pact Admiral DCB. The data were presented by Michael R. Jaff, DO, who is Medical Director of Mass General Vascular Center at the Massachusetts General Hospital and Professor of Medicine at Harvard Medical School in Boston, Massachusetts.

Dr. Jaff presented data from the full clinical cohort of 1,406 patients from the postmarket IN.PACT Global Study. The 1-year data demonstrated a low CD-TLR rate of 7.5% in a population with a mean lesion length of 12.09 cm, 18% in-stent restenosis (ISR) lesions, and 35.5% occluded lesions. Additional safety and efficacy outcomes also included low rates of thrombosis (2.9%), occurrences of major target limb amputation (0.2%), and clinically driven target vessel revascularization (8.1%) within 1 year.

Dr. Jaff commented in the company’s announcement, “Despite the complexity of these challenging lesions and patients, the outcomes were consistent across all patients, including the imaging subsets. Complex lesion types, including long lesions, chronic total occlusions, and ISR, remain challenging to treat with no clearly superior treatment options. These results demonstrate the effectiveness of the In.Pact Admiral DCB as a primary therapy in treating these challenging patients who we routinely see in clinical practice.”

Medtronic advised that the IN.PACT Global Study has enrolled more than 1,500 patients across 27 countries to characterize the performance of the In.Pact Admiral DCB in treating real-world patients with challenging and complex lesions. The study included external monitoring and adjudication of events by an independent clinical events committee. Additionally, it included core lab evaluations for prespecified imaging subsets for subjects with long lesions (≥ 15 cm) (n = 157), chronic total occlusions (≥ 5 cm) (n = 126), and ISR lesions (n = 131), as recently presented at international conferences.