PR99427

GENEVA, Jan. 11, 2023 /PRNewswire=KYODO JBN/

    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

lesions.

    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 (ClinicalTrials.gov

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: www.medalliance.com　

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

    Source: MedAlliance