MedAlliance’s Selution SLR Evaluated in LOVE-DEB Coronary Study in UK

September 6, 2023—MedAlliance announced that the first patient has been enrolled in LOVE-DEB, a prospective study in the United Kingdom evaluating the safety and efficacy of the company’s Selution SLR sirolimus drug-eluting balloon (DEB) in treating large-vessel (≥ 2.75 mm) de novo coronary artery disease. Selution SLR provides a controlled, sustained release of sirolimus, noted the company.

The trial was initiated and the first patient enrolled by physicians at the Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust, located in the metropolitan borough of Wigan and Wrightington, England, in Greater Manchester, United Kingdom.

According to the company, the study’s primary objective is to evaluate the proportion of patients who underwent target lesion revascularization within 1 year of the procedure.

“The LOVE-DEB study is a unique trial in which we are assessing the safety and efficacy of sirolimus DEB in de novo disease only in the large coronary arteries in routine clinical practice,” commented Principal Investigator Abhishek Kumar, MBBS, in the company’s press release. “We aim to recruit 300 patients over a period of 12 months across 10 centers in the United Kingdom. I am extremely delighted that we have kick-started the study by recruiting our first patient in the study at Wigan. I am very grateful for the invaluable support from all those who are involved in this study.” Dr. Kumar is consultant cardiologist at Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust.

The Selution SLR DEB received CE Mark approval for the treatment of coronary artery disease in May 2020. The device is commercially available in Europe, Asia, the Middle East, and the Americas (outside the United States) and most other countries where the CE Mark is recognized.

MedAlliance is a Switzerland-based medical technology company specializing in the development and commercialization of drug-device combination products for the treatment of coronary and peripheral artery disease. In October 2022, Cordis announced it would acquire MedAlliance.