Medtronic, a healthcare products manufacturer headquartered in Minneapolis has announced that it has successfully completed a large research study of its new drug-eluting balloon, dubbed the IN.PACT Admiral. The milestone could bode well for its regulatory clearance by the United States Food and Drug Administration (FDA). Once cleared by the agency, the device would be the first device in its class to enter the U.S. market.
According to a company announcement, the IN.PACT Admiral is designed to treat proximal popliteal and superficial femoral arteries for peripheral artery disease (PAD). The clinical study comprised 181 patients at 40 different healthcare centers in the United States. An additional 150 patients are enrolled in Europe. All data from the study will be used to pursue a premarket approval (PMA) for the device in the United States. The PMA application will be filed after the study reaches its one-year patency endpoints.
Previous overseas trials of the device have yielded positive results. In these trials, the company’s drug-eluting balloons have demonstrated efficacy in adverse event reduction, late lumen loss reduction and lesion revascularization levels.
"With 7 femoropopliteal trials featuring IN.PACT drug-eluting balloons presented at medical meetings and 5 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,” said Tony Semedo, the senior vice president of the company in prepared remarks.