GENEVA, May 5, 2023 /PRNewswire/ -- Dr. Arthur Lee, Cardiac
SELUTION4SFA is taking place at more than 30 US centers and 10 other centers around the world. The study will enroll 300 patients, with the goal of demonstrating the superiority of SELUTION SLR over balloon angioplasty (POBA). The primary efficacy endpoint is primary patency of the target lesion at 12 months and the primary safety endpoint is no death at 30 days. Participation in the study will end at the end of 2023.
"We are delighted to introduce the first sirolimus DEB to US patients and look forward to enrolling this important study quickly," said Jay Mathews, MD, co-principal investigator from Manatee Memorial Hospital in Bradenton, Florida. "We look forward to learning how this technology can potentially benefit patients with complex peripheral arterial disease."
"We are pleased to initiate our third IDE study in US patients and look forward to the results of these three studies, as well as future IDE studies," added Jeffrey B. Jump, President and CEO of MedAlliance.
SELUTION SLR obtained CE Mark approval for the treatment of coronary artery disease in May 2020. MedAlliance was the first drug-eluting balloon company to receive FDA breakthrough designation. Three IDE clinical studies are currently evaluating SELUTION SLR in the US: in CLTI patients with BTK disease; SFA/PPA; and coronary ISR. In addition, MedAlliance received IDE approval for de novo coronary lesions in January 2023. This complements the significant experience the company has gained with the SELUTION DeNovo and SUCCESS trials in Europe.
MedAlliance's unique DEB technology consists of MicroReservoirs containing a biodegradable polymer blend interspersed with the anti-restenotic drug sirolimus, coated onto the surface of an angioplasty balloon. These microreservoirs provide a controlled and sustained release of the drug for up to 90 days. MedAlliance's patented CAT™ (Cell Adherent Technology) allows microreservoirs to be coated onto balloons and efficiently transferred to adhere to the vessel lumen when delivered by balloon expansion.
SELUTION SLR is commercially available in Europe, Asia, the Middle East and the Americas (outside the US) and most other countries where the CE mark is recognized. More than 10,000 units have been used for treatment of patients in routine clinical practice or as part of coronary clinical trials. Please contact us if your center is interested in participating in this study.
MedAlliance is a medical technology company that Cordis acquired in stages in October 2022. It is headquartered in Nyon, Switzerland. MedAlliance specializes in the development of innovative technology and the commercialization of combination products of advanced drugs and devices for the treatment of coronary and peripheral arterial diseases. For more information, visit: www.medalliance.com
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