19 October 2022 | Wednesday | News
Cordis is a worldwide leader in the development and manufacturing of interventional cardiovascular and endovascular technologies. MedAlliance's innovative and revolutionary sustained sirolimus drug eluting balloon (DEB) program, SELUTION SLR™ (Sustained Limus Release), provides a flagship product family which complements Cordis' existing product portfolio, sales, marketing and distribution expertise. Cordis customers will benefit from the extensive clinical study program and publication plan that is being executed by MedAlliance to further Cordis' heritage of bringing innovative products to patients.
MedAlliance is headquartered in Nyon, Switzerland. It specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products, initially for the treatment of coronary and peripheral artery disease. SELUTION SLR, is a novel sirolimus-eluting balloon platform technology.
"We are very fortunate to find a partner like Cordis, with its strong history of innovation. The company that introduced sirolimus drug eluting stents (DES) in 1999 will be introducing the SELUTION SLR sustained limus release sirolimus drug eluting balloons (DEB), avoiding permanent metal implants and providing patients around the world with stent-less PCI," commented Jeffrey B. Jump, Chairman and CEO of MedAlliance.
"Nearly twenty years ago, Cordis introduced CYPHER®, the first drug-eluting stent, transforming cardiovascular treatment for patients around the world," said Shar Matin, Cordis CEO. "As a newly independent company, we are beyond proud to further our legacy of innovation and market disruption with MedAlliance and the first MicroReservoir sirolimus drug-eluting balloon, SELUTION SLR."
"I am excited to report on the positive SELUTION SLR data to date, with first-hand experience of the impressive clinical outcomes from patients treated with SELUTION SLR in Japan, India, Europe, and South America. We are now leading the effort to emulate these results in the United States. This technology has the distinct opportunity to change the treatment paradigm for patients suffering from cardiovascular and peripheral vascular disease," commented George Adams, Principal Investigator of the US SELUTION4SFA IDE study, Director, Cardiovascular and Peripheral Vascular Research; Rex Hospital Inc., Raleigh, North Carolina, United States.
SELUTION SLR was awarded CE Mark Approval for the treatment of peripheral artery disease in February 2020 and for the treatment of coronary artery disease in May 2020. The US FDA has awarded SELUTION SLR with four breakthrough designations: for the treatment of atherosclerotic lesions in native coronary arteries; coronary in-stent restenosis; peripheral below-the-knee and Arteriovenous Fistula in patients on hemodialysis. Coronary, BTK and SFA indications have received FDA IDE approval and IDE clinical studies are currently enrolling.
More than 500 patients of the 3,326 planned have already been enrolled in the ground-breaking coronary randomized controlled study comparing SELUTION SLR with any limus drug-eluting stent (DES), powered to demonstrate superiority of SELUTION SLR DEB over DES. SELUTION DeNovo is the largest DEB study ever initiated and has the potential to change medical practice.
SELUTION SLR's technology involves unique MicroReservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These MicroReservoirs provide controlled and sustained release of the drug for up to 90 days. Extended release of sirolimus from stents has been proven highly efficacious in both coronary and peripheral vasculatures. MedAlliance's proprietary CAT™ (Cell Adherent Technology) enables the MicroReservoirs to be coated onto balloons and adhere to the vessel lumen when delivered via an angioplasty balloon.
SELUTION SLR is available in Europe and all other countries where the CE Mark is recognized.