Medtronic has completed patient enrollment in controlled, multicenter, prospective IN.PACT SFA II clinical trial of its IN.PACT Admiral drug-eluting balloon device for treating patients with peripheral artery disease in the superficial femoral and proximal popliteal arteries.
The CE-marked device features a proprietary FreePac coating, which comprises paclitaxel and urea, an excipient that facilitates absorption of the drug into the vessel wall.
Medtronic said the trial forms part of the company’s IN.PACT clinical program, which includes 29 studies involving more than 4,600 patients at 230 sites.
The ongoing trial, which has enrolled 181 patients, has randomized them in 2:1 ratio to receive treatment with either the company’s IN.PACT Admiral drug-eluting balloon (study arm) or a conventional non-coated angioplasty balloon (control arm).
The primary endpoint of the trial is primary patency, a measure of blood flow through the treated arterial segment, at 12 months, claims the company.
The company said it will combine the results of IN.PACT SFA II trial with the company’s 150 patient-based IN.PACT SFA I trial, for submitting premarket approval (PMA) application to the US Food and Drug Administration (FDA).
As part of the clinical program, the company is also enrolling 1,500 patients from 80 sites in the IN.PACT global study for evaluating IN.PACT drug-eluting balloons in patients with femoropopliteal lesions of any length.
Medtronic senior vice president and endovascular therapies business president Tony Semedo said, "With seven femoropopliteal trials featuring IN.PACT drug-eluting balloons presented at medical meetings and five of them already published in peer-reviewed journals, Medtronic is on track to deliver this technology to U.S. physicians in a timely manner with an unprecedented volume of high-quality clinical data to support its adoption."
IN.PACT Admiral, which is an investigational device in the US, is not available for sale.