GENEVA, Sept. 15, 2023 /PRNewswire/ -- MedAlliance has announced the enrollment of more than 1,660 patients in its groundbreaking SELUTION DeNovo randomized coronary study. Recruitment is now halfway to the planned 3,326 patients. SELUTION DeNovo compares the treatment strategy using a new sirolimus drug-eluting balloon (SELUTION SLR) with any sirolimus drug-eluting stent (DES).
SELUTION DeNovo is the largest DEB study ever initiated and involves up to 70 participating sites 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 (TVF) at five years.
This study is designed to change medical practice, as most de novo coronary lesions are currently treated with a permanent metallic stent. SELUTION SLR consists of an angioplasty balloon coated with MicroReservoirs containing a biodegradable polymer blend and the antirestenotic drug sirolimus. These MicroReservoirs provide controlled, sustained drug release over 90 days, similar to a DES, but without leaving behind a metal stent, which has been associated with a complication rate of 2% per year.
"This is an important milestone for the SELUTION DeNovo trial as it is now the largest DEB study ever conducted," said co-principal investigator Professor Christian Spaulding, Department of Cardiology, Georges Pompidou European Hospital, Assistance Publique Hôpitaux de Paris and the Paris Cité University, Paris, France. "The study is being done in a truly interested population and is not just looking at small vessel artery disease. It is encouraging that the Drug and Safety Monitoring Board has no concerns and voted unanimously for the trial to continue as planned, "As there are no concerning protocol deviations or significant differences between the groups. We see that the investigators are comfortable using this novel approach and we expect enrollment to be completed in the next 12 months."
"This trial has the potential to change medical practice, not only in Europe, but also in the US, China and Japan, benefiting patients around the world," added Jeffrey B. Jump, president and CEO of MedAlliance. . "We are currently enrolling US patients in our IDE coronary ISR, peripheral BTK and SFA studies. The SELUTION4DeNovo IDE coronary trial should enroll its first US patient in early Q4 2023."
SELUTION SLR received 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 FDA IDE approval in May and August 2022, MedAlliance received in-stent coronary restenosis (ISR) IDE approval in October 2022 and de novo approval for coronary artery 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 involves microreservoirs containing a biodegradable polymer blend intermixed with the anti-restenotic drug sirolimus applied as a coating on the surface of an angioplasty balloon. These MicroReservoirs provide controlled and sustained drug release for up to 90 days. MedAlliance's patented CAT™ (Cell Adherent Technology) technology allows microreservoirs to be coated on balloons and efficiently transferred to adhere to the vessel lumen when administered 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 40,000 units have been used to treat patients in routine clinical practice or as part of coronary clinical trials.
MedAlliance is a medical technology company that announced a phased acquisition by Cordis in October 2022. Headquartered in Nyon, Switzerland, MedAlliance specializes in the development of innovative technology and the commercialization of combination products of advanced pharmacological devices for the treatment of coronary and peripheral arterial diseases. For more information, visit: www.medalliance.com
Richard Kenyonrkenyon@medalliance.com 44 7831 569940
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