Country for PR: United Kingdom
Contributor: PR Newswire Europe
Wednesday, January 11 2023 - 11:00
MedAlliance SELUTION SLR is the first DEB to receive coronary de novo IDE approval, its fourth FDA IDE DEB Approval
GENEVA, Jan. 11, 2023 /PRNewswire-Asianet/

    SELUTION SLR(TM), MedAlliance's novel sirolimus-eluting balloon, has 
received conditional FDA Investigational Device Exemption (IDE) approval to 
initiate its pivotal clinical trial for the treatment of coronary de novo 

    This comes less than eight months after the company received its first IDE 
approval for SELUTION SLR in the treatment of below-the-knee (BTK) indications; 
as well as occlusive disease of the superficial femoral artery (SFA); and 
coronary In-Stent Restenosis (ISR).

    Enrollment of the SELUTION SLR coronary de novo study will begin in the US 
within the next few months.

    This will complement the substantial experience that the company has 
already gained with the SELUTION DeNOVO trial in Europe ( 
Identifier: NCT04859985). More than 800 patients of the 3,326 planned have been 
enrolled in this ground-breaking coronary randomized controlled study comparing 
SELUTION SLR vs. any limus drug-eluting stent (DES). The study is powered to 
demonstrate superiority of SELUTION SLR drug-eluting balloon (DEB) over DES in 
coronary de novo artery disease. This is the largest DEB study ever initiated 
and has the potential to change medical practice where implants (metal stents) 
have been the standard of care for more than 30 years.

    "Treatment of de novo coronary arteries with drug-eluting balloons is a 
breakthrough in revascularization of coronary artery disease. The SELUTION SLR 
coronary de novo study is the first of its kind in the USA and will provide 
important data on the efficacy and safety of sirolimus- eluting balloon as a 
viable alternative to drug-eluting stent, leaving nothing behind post-PCI and 
eliminating in-stent restenosis and related complications," said Dr. Ron 
Waksman, Professor of Cardiology at Georgetown University, Director of 
Cardiovascular Research at MedStar Heart and Vascular Institute, Washington DC  
and Chairman of the MedAlliance Coronary Study Steering Committee.

    "Coronary de novo lesions are the largest potential opportunity for use of 
DEB's: the data has shown clearly that DES don't work well in small vessels, 
long, or bifurcated lesions or in patients with diabetes or risk of high 
bleeding complications. These patients represent 60% of all patients currently 
treated with DES, who may now benefit from this exciting new DEB technology," 
added Jeffrey B. Jump, Chairman and CEO of MedAlliance.

    SELUTION SLR was awarded CE Mark Approval for the treatment of peripheral 
artery disease in February 2020 and for the treatment of coronary artery 
disease in May 2020.

    MedAlliance's unique DEB technology involves MicroReservoirs which contain 
a mixture 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.

    SELUTION SLR 014 PTCA 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 10,000 coronary units have already been used for patient 
treatment in routine clinical practice or as part of clinical trials.

    About MedAlliance

    MedAlliance is a 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:


    Logo: MedAlliance