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.
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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.
About Cordis
Cordis is a worldwide leader in the development and manufacturing of interventional cardiovascular technologies with a more than 60-year history of pioneering breakthrough therapies to treat millions of patients. With a reputation for clinical acumen, training, and service, Cordis has a legacy of innovation in high-quality and minimally invasive cardiovascular products, building a strong global footprint with operations in more than 70 countries around the world.
SOURCE MedAlliance
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