US-based medical technology company Medtronic has finished enrolling patients for clinical trials of its IN.PACT Admiral drug-eluting balloon device for treating patients with peripheral artery disease in the superficial femoral arteries (SFA) and proximal popliteal arteries (PPA).
The CE-marked device features a proprietary FreePac coating, which is a formulation of paclitaxel and urea, an excipient that facilitates absorption of the drug into the vessel wall.
The controlled, multicentre, prospective trial, named IN.PACT SFA II, forms part of the company's IN.PACT clinical programme, which includes 29 studies involving more than 4,600 patients at 230 sites.
The ongoing trial of 181 patients from more than 40 US sites has randomised them in a 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 includes primary patency, a measure of blood flow through the treated arterial segment, at 12 months.
Medtronic intends to combine the results obtained from the IN.PACT SFA II trial with its 150 patient-based IN.PACT SFA I trial, to submit a premarket approval (PMA) application to the US Food and Drug Administration (FDA).
As part of the clinical programme, the company is enrolling 1,500 patients from 80 sites in the global study to evaluate 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 US physicians in a timely manner with an unprecedented volume of high-quality clinical data to support its adoption."
IN.PACT Admiral is an investigational device in the US and is not available for sale.
Image: Medtronic corporate headquarters in Fridley, Minnesota, US. Photo: courtesy of Bobak Ha'Eri.