Thursday, September 07, 2023
The inaugural participant has been officially enrolled in a research endeavor based in the United Kingdom. This study is dedicated to the treatment of de novo coronary artery disease within large blood vessels using a groundbreaking medical device known as SELUTION SLR™. It is noteworthy that this clinical investigation is being conducted by a team of dedicated physicians affiliated with the Wrightington, Wigan, and Leigh Teaching Hospitals NHS Foundation Trust, which also serves as the location where the first participant was enrolled. SELUTION SLR represents an innovative sirolimus-eluting balloon designed to deliver controlled and sustained drug release, closely resembling the mechanisms of a drug-eluting stent (DES).
Termed the LOVE-DEB Study (Large de-NOVo coronary artery disease treated with sirolimus Drug Eluting Balloon), this prospective evaluation seeks to assess the safety and efficacy of SELUTION SLR in treating native de novo coronary artery disease within larger vessels (those with a diameter of ≥2.75mm). The primary aim of this research is to gauge the percentage of patients requiring Target Lesion Revascularization (TLR) within the first year following their procedure.
Dr. Abhishek Kumar, a Consultant Cardiologist at the Wrightington, Wigan, and Leigh Teaching Hospitals NHS Foundation Trust and the Principal Investigator of the study, expressed enthusiasm, stating, "The LOVE-DEB Study represents an extraordinary trial in which we are specifically scrutinizing the safety and effectiveness of sirolimus DEB for de novo disease in the larger coronary arteries within our routine clinical practice. We are striving to enroll a total of 300 patients over a 12-month period, spanning 10 different centers across the United Kingdom. It is with great pleasure that we announce the commencement of this study with the enrollment of our inaugural patient in Wigan. We extend our heartfelt appreciation to all those who are contributing to the triumph of this research."
Jeffrey B. Jump, Chairman and CEO of MedAlliance, added further insights, remarking, "Even though these medical institutions have already integrated our pioneering technology into their daily clinical workflows, we are eagerly anticipating the outcomes within this less-explored yet highly significant patient cohort, particularly in light of drug-eluting stents showing a complication rate exceeding 2% per annum."
MedAlliance holds the distinction of being the first company dedicated to drug-eluting balloons to attain FDA Breakthrough Designation status. At present, the company is overseeing three Investigational Device Exemption (IDE) clinical studies assessing SELUTION SLR within the United States: for patients dealing with critical limb-threatening ischemia (CLTI) with below-the-knee (BTK) disease; superficial femoral artery (SFA) and popliteal artery (PPA) conditions; and coronary in-stent restenosis (ISR). Moreover, MedAlliance secured Investigational Device Exemption (IDE) approval for de novo coronary artery lesions in January 2023.
SELUTION SLR received CE Mark Approval for the treatment of coronary artery disease in May 2020, marking a significant milestone building on the company's extensive experience derived from the SELUTION DeNovo and SUCCESS trials in Europe, as well as the SELUTION SFA trial in Japan.
The unique drug-eluting balloon (DEB) technology developed by MedAlliance incorporates MicroReservoirs that house a blend of biodegradable polymer and the anti-restenotic drug sirolimus. These MicroReservoirs are applied as a coating on the surface of an angioplasty balloon, ensuring controlled and sustained drug release for a duration of up to 90 days. The company's proprietary CAT™ (Cell Adherent Technology) facilitates the efficient transfer and adhesion of the MicroReservoirs to the vessel lumen during balloon expansion.
Notably, SELUTION SLR is currently available for commercial use in Europe, Asia, the Middle East, and the Americas (with the exception of the USA), as well as in most other regions acknowledging the CE Mark. To date, more than 50,000 units of this innovative device have been employed for patient treatments in routine clinical practice and coronary clinical trials.