Medtronic has released results from the IN.PACT drug-eluting balloon (DEB) clinical program and has also initiated a key clinical study of the IN.PACT Admiral (DEB) for the treatment of superficial femoral artery (SFA) disease.
Medtronic’s IN.PACT drug-eluting balloons feature a hydrophilic coating called FreePac that frees and separates paclitaxel molecules, facilitating their absorption into the vessel wall to mitigate re-narrowing of the artery over time.
University of Saarland in Homburg/Saar, Germany, Internal Medicine and Cardiology professor Bruno Scheller said that based on a growing body of clinical data and while results of randomised trials are awaited, IN.PACT drug-eluting balloons show promise for the treatment of both coronary and peripheral artery disease.
“The best potential applications appear to be in atherosclerotic leg vessels and for previously stented coronary arteries that have restenosed,” Scheller said.
The IN.PACT clinical program includes studies on the treatment of de-novo coronary lesions and coronary in-stent restenosis, as well as below-the-knee (BTK) and superficial femoral artery (SFA) disease.
Medtronic has also presented data from IN.PACT CORO ISR, a single-center, single-arm confirmatory study of the IN.PACT Falcon DEB for the treatment of coronary in-stent restenosis.
IN.PACT SFA I trial, the newly initiated study, is expected to assess thesafety and efficacy of the IN.PACT Admiral paclitaxel-eluting percutaneous transluminal angioplasty (PTA) balloon catheter in the SFA compared to treatment with a standard PTA balloon.