The first patient has been enrolled in a UK study of large vessel de novo coronary artery disease treated with Selution SLR (MedAlliance) sirolimus-eluting balloon.
This is a trial initiated by physicians at the Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust, where the first patient was enrolled.
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 revascularisation (TLR) within one year of their 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,” the study’s principal investigator, Abhishek Kumar (Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust, Wigan, UK), said. “We aim to recruit 300 patients over a period of 12 months across 10 centres in the UK. 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.”
“Although these centres have already adopted our novel technology in their daily practice, we are excited to see the results in this understudied important patient population, where drug-eluting stents have demonstrated a greater than 2% complication rate per year,” added Jeffrey B Jump, chairman and CEO of MedAlliance.
Currently three investigational device exemption (IDE) clinical studies are evaluating Selution SLR in the USA: in chronic limb-threatening ischaemia (CLTI) patients with below-the-knee (BTK) disease; superficial femoral artery (SFA) and proximal popliteal artery (PPA); and coronary in-stent restenosis (ISR).
In addition, MedAlliance received IDE approval from the US Food and Drug Administration (FDA) 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 experience that the company has gained with the SELUTION DeNovo and SUCCESS trials in Europe & SELUTION SFA in Japan.
MedAlliance’s drug-eluting balloon technology involves micro reservoirs which contain a combination of biodegradable polymer intermixed with the antirestenotic drug sirolimus, applied as a coating on the surface of an angioplasty balloon. These micro reservoirs provide controlled and sustained release of the drug for up to 90 days.
MedAlliance’s proprietary cell adherent technology (CAT) enables the micro reservoirs 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 recognised. Over 50,000 units have been used for patient treatments in routine clinical practice or as part of coronary clinical trials.