预约演示

MedAlliance announces enrollment of First Patient in SELUTION SLR LOVE-DEB Coronary Study

2023-09-05

并购临床研究

GENEVA, Sept. 5, 2023 /PRNewswire/ -- 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).

First Patient Enrolled in SELUTION SLR LOVE-DEB Coronary Stud

The aim of the LOVE-DEB Study (

Large de-N

OVo coronary art

Ery disease treated with sirolimus

Ery disease sirolimus

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 clcoronary artery disease 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, sirolimus DEBd 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 balloon company 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 aMedAlliancens 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 surfaceBTK diseaseoplasty balloon. These MicroReservoirs proMedAlliancelled and sustained release of the drug for up to 90 days. MedAlliance's proprietary CAT™ (Cell Adherent Technology) enables the MicroReservcoronary artery diseaseballoons and efficiently transferred to adhere to the vessel lumen when delivered via expansion of the balloon.

MedAllianceR is commercially available in Europe, Asia, the Middle East, and the Americas (outside USA) and most other countries where the CE Mark is recogsirolimuser 50,000 units have been used for patient treatments in routine clinical practice or as part of coronary clinical trials.MedAlliance

Media Contact:

Richard Kenyon

[email protected]

+44 7831 569940

About MedAlliance

MedAllMedAlliancedical technology company which announced a staged acquisition by Cordis in October 2022. It is headquartered in Nyon, Switzerland. MedAlliance specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. For further information visit: www.medalliance.com

MedAlliances://mma.prnewswire.com/media/2201455/First_Patient_SELUTION_SLR_LOVE_DECordis MedAlliance coronary and peripheral artery disease

Logo: https://mma.prnewswire.com/media/1196864/MedAlliance_Logo.jpg

SOURCE MedAlliance