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GENEVA, March 16, 2023 /PRNewswire/ -- MedAlliance has announced the enrollment of more than 1,000 patients in its groundbreaking SELUTION DeNovo randomized coronary study. One third of the recruitment has already been completed to reach the goal of 3,326 patients. SELUTION DeNovo compares the treatment strategy with a new sirolimus-eluting balloon [DEB SELUTION] versus a limousine-eluting stent [DES].
SELUTION DeNovo is the largest DEB study ever initiated, with up to 70 participating centers in 15 countries. Patients are randomized prior to any vessel preparation to reflect current medical practice and reduce bias. The objectives of the study are to demonstrate non-inferiority at one and five years, and superiority for target vessel failure (VFD) at five years.
This study aims to change medical practice, since currently most de novo coronary lesions are treated with a permanent metal stent. SELUTION SLR consists of an angioplasty balloon coated with MicroReservoirs containing a biodegradable polymer blend and the anti-restenotic drug sirolimus. These microreservoirs provide a controlled and sustained release of the drug for more than 90 days, similar to that of a DES, but without leaving behind a metal scaffold, which has been associated with a 2% annual complication rate.
"This is an important milestone for the SELUTION DeNovo trial, as it is the largest DEB study conducted to date," said co-principal investigator Professor Christian Spaulding, from the Cardiology Service of the Georges Pompidou European Hospital, La Assistance Publique Hôpitaux de Paris and Paris Cité University, Paris, France. "The study is conducted in a true population of patients with all types of conditions and is not limited to small-vessel artery disease. The results will have a major impact on clinical practice."
"This trial has the potential to change medical practice, not only in Europe, but also in the United States, China and Japan, benefiting patients around the world," added Jeffrey B. Jump, President and CEO of MedAlliance. "We are currently enrolling American patients in our ISR IDE and BTK coronary studies in the United States and Europe."
SELUTION SLR gained 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. In addition to the BTK and superficial femoral artery (SFA) indications for which the company received IDE approval from the FDA in May and August 2022, MedAlliance received IDE approval for in-stent coronary restenosis (ISR) in October 2022. 2022 and approval for de novo coronary lesions on January 6, 2023. This will complement the significant experience the company has gained with the SELUTION DeNovo trial 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) technology enables microreservoirs to be coated on balloons and transferred efficiently so that they adhere to the lumen of the vessel when delivered by balloon expansion.
SELUTION SLR is commercially available in Europe, Asia, the Middle East, and the Americas (outside the United States) and in most other countries where the CE mark is recognised. More than 10,000 units have been used for treatment of patients in routine clinical practice or as part of coronary clinical trials.
Richard Kenyonrkenyon@medalliance.com 44 7831 569940
MedAlliance is a medical technology company acquired by Cordis in stages in October 2022. Headquartered in Nyon, Switzerland, MedAlliance specializes in the development of innovative technology and the commercialization of advanced drug and device combination products for the treatment of coronary and peripheral artery disease. For more information, visit the website: www.medalliance.com
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