News | Drug-Eluting Balloons | September 11, 2023

MedAlliance Announces Enrollment of First Patient in SELUTION SLR LOVE-DEB Coronary Study

The first patient has been enrolled in a UK study of large vessel de novo coronary artery disease treated with SELUTION SLR

September 11, 2023 — The first patient has been enrolled in a UK study of large vessel de novo coronary artery disease treated with SELUTION SLR. This is a trial initiated by physicians at the Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust, which is where the first patient was enrolled. SELUTION SLR is a novel sirolimus-eluting balloon that provides a controlled sustained release of drug, similar to a drug-eluting stent (DES). 

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 Revascularization (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. 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. I am very grateful for the invaluable support from all those who are involved in this study,” commented Principal Investigator Dr Abhishek Kumar, Consultant Cardiologist, Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust

“Although these centers 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.  

MedAlliance was the first drug-eluting ballooncompany to receive FDA Breakthrough Designation status.  Currently three IDE clinical studies are evaluating SELUTION SLR in the US: in CLTI patients with BTK disease; SFA/PPA; and coronary ISR. In addition, MedAlliance received IDE approval 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 substantial experience that the company has gained with the SELUTION DeNovo and SUCCESS trials in Europe & SELUTION SFA in Japan. 

MedAlliance’s unique DEB technology involves MicroReservoirs which contain a combination of biodegradable polymer intermixed with the anti-restenotic drug sirolimus, applied as a coating on the surface of an angioplasty balloon. These MicroReservoirs provide controlled and sustained release of the drug for up to 90 days. MedAlliance’s proprietary CAT (Cell Adherent Technology) enables the MicroReservoirs 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 recognized. Over 50,000 units have been used for patient treatments in routine clinical practice or as part of coronary clinical trials. 

For more information: www.medalliance.com 

 

Related Selution Content: 

Excellent 12-Month Results from SELUTION SFA Trial Presented at JET  

Over 1,000 Patients Enrolled in Landmark SELUTION DeNovo Study   

MedAlliance Selution SLR is the First DEB to Receive Coronary de novo IDE Approval, its Fourth FDA IDE DEB Approval   

First US Patient Enrolled in SELUTION SLR IDE Peripheral Study    

MedAlliance SELUTION SLR Receives Coronary FDA IDE Approval    

MedAlliance’s SELUTION SLR Drug-eluting Balloon Receives FDA Investigational Device Exemption Approval   

First US Patient Enrolled in SELUTION SLR IDE Peripheral Study  

MedAlliance SELUTION SLR Receives Coronary FDA IDE Approval  

MedAlliance’s SELUTION SLR Drug-eluting Balloon Receives FDA Investigational Device Exemption 


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