The first patient has been enrolled in a UK study of large vessel de novo coronary artery disease treated with Selution SLR.
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This is a trial initiated by physicians at the Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust, which is where the first patient was enrolled.
Selution SLR is a novel sirolimus-eluting balloon that provides a controlled sustained release of drug, similar to a drug-eluting stent (DES).
The aim of the LOVE-DEB Study (Large de-NOVo coronary artEry disease treated with sirolimus Drug Eluting Balloon: prospective evaluation of safety & efficacy of Selution SLR drug eluting balloon) is to evaluate the safety and efficacy of Selution SLR in treating native de novo coronary artery disease in larger vessels (≥2.75mm).
Its primary objective is to evaluate the proportion of patients who underwent Target Lesion Revascularization (TLR) within one year of their procedure.
MedAlliance was the first drug eluting balloon company to receive FDA Breakthrough Designation status.
Currently three IDE clinical studies are 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 artery lesions in January 2023. Selution SLR was awarded CE Mark Approval for the treatment of coronary artery disease in May 2020.
This complements the substantial experience that the company has gained with the Selution DeNovo and success trials in Europe & Selution SFA in Japan.
MedAlliance's unique DEB technology involves MicroReservoirs which contain a combination of biodegradable polymer intermixed with the anti-restenotic drug sirolimus, applied as a coating on the surface of an angioplasty balloon.
These MicroReservoirs provide controlled and sustained release of the drug for up to 90 days. MedAlliance's proprietary CAT (Cell Adherent Technology) enables the MicroReservoirs to be coated onto balloons and efficiently transferred to adhere to the vessel lumen when delivered via expansion of the balloon.
Selution SLR is commercially available in Europe, Asia, the Middle East, and the Americas outside USA and most other countries where the CE Mark is recognized. Over 50,000 units have been used for patient treatments in routine clinical practice or as part of coronary clinical trials. ■