The inaugural participant has been enrolled in a study based in the United Kingdom focusing on the treatment of large vessel de novo coronary artery disease using SELUTION SLR™. This research initiative is spearheaded by medical professionals affiliated with the Wrightington, Wigan, and Leigh Teaching Hospitals NHS Foundation Trust, where the first patient became part of the study. SELUTION SLR represents a groundbreaking sirolimus-eluting balloon that delivers a controlled, sustained release of medication, akin to a drug-eluting stent (DES).

The primary objective 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 assess the safety and effectiveness of SELUTION SLR in addressing native de novo coronary artery disease within larger vessels (≥2.75mm). Its principal aim is to gauge the percentage of patients necessitating Target Lesion Revascularization (TLR) within one year following their procedure.

Dr. Abhishek Kumar, Consultant Cardiologist at the Wrightington, Wigan, and Leigh Teaching Hospitals NHS Foundation Trust and the Principal Investigator of the study, expressed, "The LOVE-DEB Study is a distinctive trial wherein we are examining the safety and effectiveness of sirolimus DEB exclusively in cases of de novo disease within the larger coronary arteries, in the context of routine clinical practice. We aspire to enroll 300 patients over the course of 12 months across 10 medical centers in the UK. I am thrilled that we have commenced the study with the recruitment of our first patient in Wigan, and I extend my heartfelt appreciation to all those involved in this research."

Jeffrey B. Jump, Chairman and CEO of MedAlliance, added, "Although these centers have already integrated our innovative technology into their daily practices, we are eager to observe the outcomes in this less-researched but crucial patient group, where drug-eluting stents have exhibited an annual complication rate exceeding 2%."

It's noteworthy that MedAlliance was the pioneer in gaining FDA Breakthrough Designation status for drug-eluting balloons. Currently, three Investigational Device Exemption (IDE) clinical studies in the United States are scrutinizing SELUTION SLR's effectiveness in patients with CLTI and BTK disease, SFA/PPA, and coronary ISR. Moreover, MedAlliance secured IDE approval for de novo coronary artery lesions in January 2023. SELUTION SLR attained CE Mark Approval for the treatment of coronary artery disease in May 2020. These achievements complement the substantial experience MedAlliance has acquired through the SELUTION DeNovo and SUCCESS trials in Europe, as well as SELUTION SFA in Japan.

MedAlliance's unique drug-eluting balloon technology incorporates MicroReservoirs that house a blend of biodegradable polymer and the anti-restenotic drug sirolimus. This combination is applied as a coating on the surface of an angioplasty balloon. The MicroReservoirs enable a controlled and sustained release of the drug for up to 90 days. MedAlliance's proprietary CAT™ (Cell Adherent Technology) facilitates the coating of MicroReservoirs onto balloons and their efficient transfer to adhere to the vessel lumen during balloon expansion.

SELUTION SLR is readily available in Europe, Asia, the Middle East, and the Americas (excluding the USA), as well as most other countries where the CE Mark is recognized. To date, more than 50,000 units have been employed for patient treatments in routine clinical practice and as part of coronary clinical trials.

 

Source: prnewswire.com

Report Abuse