Medtronic (NYSE:MDT) touted data for its In.Pact Admiral drug-coated balloon this week at the Vascular Interventional Advances (VIVA) 2017 conference.
The company presented two-year, real-world data from the In.Pact Global study, as well as four-year results from the pivotal In.Pact SFA study.
Data from the In.Pact Global study showed a 83.3% rate of freedom from clinically-driven target lesion revascularization in a real-world patient cohort with a mean lesion length of 12.09 centimeters, 18% in-stent restenosis lesions, 36% occluded lesions and 40% with diabetes.
The company also reported a 4.5% rate of thrombosis and a 0.7% rate of major target limb amputation within two years.
“At two years, the In.Pact Admiral DCB continues to confirm positive outcomes from the In.Pact randomized trials, demonstrating efficacy, safety, and durability, despite the complexity of these lesions,” Dr. Thomas Zeller said in prepared remarks. “These results also highlight the clinical utility of the In.Pact Admiral DCB as a primary therapy in treating patients with some of the most challenging PAD cases.”
Medtronic’s In.Pact Global trial is the largest real-world evaluation of any peripheral artery intervention, according to the company.
Data from Medtronic’s pivotal In.Pact SFA study showed that of the patients who received a repeat procedure within four years, the time to reintervention for those who received the In.Pact Admiral DCB was nearly double that of those in the percutaneous transluminal angioplasty group.
The drug-coated balloon had a freedom from CD-TLR rate of 76.8% compared to 70.4% for PTA, the company reported. There were also no major target limb amputations, a low rate of thrombosis and no major adverse events from three to four years in the In.Pact Admiral group.
“With the In.Pact Admiral DCB, pre-clinical studies have demonstrated that the drug remains in the tissue for approximately six months. Therefore, at four years, we would expect to see some catch up effect and at least some late progression of atherosclerosis,” Dr. Peter Schneider said. “However, in the four-year data from IN.PACT SFA, we are still seeing sustained durability and clinical benefit. For patients suffering with this chronic condition, these findings are not only encouraging from a therapeutic perspective, but are also suggestive of improved quality of life, with patients requiring fewer reinterventions over time compared to PTA and leaving future treatment options open.”
“PAD is a chronic condition associated with disease progression and often requires repeat interventions to manage the disease,” Mark Pacyna, VP & GM of Medtronic’s peripheral business, added. “In partnership with the clinical community, our objective has been to develop a safe, effective, and sustainable treatment option for these patients. The data presented today reflects this goal and our commitment to timely and transparent data releases. We are excited to see consistency in real-world patients and fewer interventions out to four years, which was statistically significant.”
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