MedAlliance, a medtech company specializing in the development of drug device combination products for the treatment of coronary and peripheral artery disease, recently announced it has enrolled its first patient in a United Kingdom-based study of large vessel de novo coronary artery disease treated with Selution SLR. The first patient was enrolled at the trial initiation location, the Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust.
The device is a sirolimus-eluting balloon that provides a controlled sustained release of a drug. The company’s drug eluting balloon technology has microreservoirs that contain a combination of biodegradable polymer intermixed with sirolimus — an anti-restenotic drug — that’s applied as a coating on the surface of an angioplasty balloon. The balloon then releases the drug for up to 90 days. Additionally, MedAlliance’s cell adherent technology enables those microreservoirs to be coated onto balloons and transferred to “adhere to the vessel lumen when delivered via expansion of the balloon,” according to a press release.
The trial, called the LOVE-DEB study (large de-novo coronary artery disease treated with sirolimus drug eluting balloon), intends to evaluate the safety and efficacy of the Selution SLR in treating native de novo coronary artery disease in larger vessels (≥2.75mm). Its primary objective is to study the proportion of patients “who underwent Target Lesion Revascularization within one year of their procedure,” MedAlliance said. The study aims to enroll 300 patients over 12 months across 10 centers in the UK.
"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,” said Dr. Abhishek Kumar, principal investigator and consultant cardiologist at Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust. “We aim to recruit 300 patients over a period of 12 months across 10 centers in the UK. I am extremely delighted that we have kick-started the study by recruiting our first patient in the study at Wigan.”
The company has received FDA Breakthrough Designation status and has three IDE studies currently underway in the US. Selution SLR obtained its CE Mark for the treatment of coronary artery disease in May 2020.