ANI PR Wire
06 Sep 2023, 11:42 GMT+10
PRNewswire
Geneva [Switzerland], September 6: 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 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 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.
Media Contact:
Richard Kenyon
[email protected]
+44 7831 569940
About MedAlliance
MedAlliance is medical 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
Photo: https://mma.prnewswire.com/media/2201455/First_Patient_SELUTION_SLR_LOVE_DEB.jpg
Logo: https://mma.prnewswire.com/media/1196864/MedAlliance_Logo.jpg
(Disclaimer: The above press release has been provided by PRNewswire. ANI will not be responsible in any way for the content of the same)
Get a daily dose of Herald Globe news through our daily email, its complimentary and keeps you fully up to date with world and business news as well.
Publish news of your business, community or sports group, personnel appointments, major event and more by submitting a news release to Herald Globe.
More InformationMOSCOW, Russia: Just hours after his sudden dismissal by President Vladimir Putin, Russia's former transport minister, Roman Starovoit,...
DHARAMSHALA, India: The Dalai Lama turned 90 on July 6, celebrated by thousands of followers in the Himalayan town of Dharamshala,...
ZAGREB, Croatia: A massive concert by popular Croatian singer Marko Perković, known by his stage name Thompson, has drawn widespread...
WASHINGTON, D.C.: Elon Musk's entry into the political arena is drawing pushback from top U.S. officials and investors, as his decision...
CULVER CITY, California: TikTok is preparing to roll out a separate version of its app for U.S. users, as efforts to secure a sale...
WASHINGTON, D.C.: President Donald Trump claimed he was unaware that the term shylock is regarded as antisemitic when he used it in...
MADRID, Spain: Liverpool footballer Diogo Jota and his younger brother, André Silva, have died in a car accident in Spain. Spanish...
New Delhi [India], July 9 (ANI): Former Australian fast bowler Gordon Rorke passed away at the age of 87. Rorke, known for his towering...
(Photo credit: Nathan Ray Seebeck-Imagn Images) Masataka Yoshida is expected to be in the lineup when the Boston Red Sox try to complete...
(Photo credit: Steven Bisig-Imagn Images) After a week of angst that saw them fall out of first place in the American League East,...
(Photo credit: Mitch Stringer-Imagn Images) New York Mets outfielder Juan Soto might be trying to prove a point this week after he...
(Photo credit: Denis Poroy-Imagn Images) Luis Arraez homered in the seventh inning to break up a scoreless tie Tuesday night and...