Medtronic has treated its first patients in its IN.PACT SFA II study, the company's first US clinical trial for its line of IN.PACT drug-eluting balloons.
The first patients in the study were treated at Washington Hospital, in Fremont, and the St. Vincent Hospital in Indianapolis, US, while Christ Hospital in Cincinnati is planning to treat a patient by next week.
The CE-marked IN.PACT drug-eluting balloons feature a proprietary coating called FreePac, which is a formulation of paclitaxel and urea, an excipient which facilitates absorption of the drug into the vessel wall.
The prospective multicentre randomised controlled trial Medtronic IN.PACT SFA II study is designed to assess the safety and effectiveness of the IN.PACT Admiral drug-eluting balloon for the treatment of peripheral artery disease.
In the IN.PACT SFA II study, patients will be randomised 2:1 for treatment with either Medtronic's IN.PACT Admiral drug-eluting balloon (study arm) or a traditional non-coated angioplasty balloon (control arm).
The trial will also evaluate the effect of the device for treating de novo and non-stented restenotic atherosclerotic lesions in these vessel beds.
Upon completion, the study data will be integrated with those from the Medtronic IN.PACT SFA I study to support a premarket approval (PMA) application to the US Food and Drug Administration (FDA).
The IN.PACT clinical programme will include 24 studies in 4,000 patients and 200 sites across more than 80 countries worldwide, and to date, seven of them have completed enrolment and ten others have begun enrolment.
Medtronic's IN.PACT Admiral drug-eluting balloon is limited to investigational use under an investigational device exemption (IDE), granted by the FDA. Headquartered in Minneapolis, US, Medtronic offers medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.
Image: The world headquarters of Medtronic in Minnesota, US. Photo: Bobak Ha'Eri.