PR96221

MedAlliance's SELUTION SLR Drug-Eluting Balloon (DEB) Receives FDA Investigational Device Exemption (IDE) Approval, Making it the First Limus DEB to be Available to US Patients

GENEVA, May 30, 2022 /PRNewswire=KYODO JBN/--

The SELUTION SLR (Sustained Limus Release) is a novel sirolimus-eluting balloon

that provides a controlled sustained drug release, similar to a drug-eluting

stent (DES). SELUTION SLR was also the first DEB (Drug Eluting Balloon) granted

"breakthrough device designation" by the FDA on March 4, 2019 and further in

September 25, 2019 for below-the-knee (BTK) indications in peripheral artery

disease.

This is a major milestone for MedAlliance. We have been able to successfully

complete the bench and pre-clinical testing required by the FDA and are ready

to begin enrolling US patients in a clinical study to support submission for

FDA PMA approval.  We are delighted that US patients may also benefit from this

"Breakthrough technology", commented Jeffrey B. Jump MedAlliance Chairman and

CEO.

Photo - https://mma.prnewswire.com/media/1827076/MedAlliance_1.jpg

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MedAlliance will begin enrollment in the Below-the-knee (BTK) IDE Randomized

Clinical Trial (RCT) SELUTION4BTK (ClinicalTrials.gov Identifier: NCT05055297)

immediately outside of US (OUS) and early this summer in US centers.  Principal

investigators of the study are Doctors Ehrin Armstrong (US), Marianne Brodmann

(Austria), and Tjun Tang (Singapore).

SELUTION SLR was awarded CE Mark Approval for the treatment of peripheral

artery disease in February 2020.  The device has shown early promising clinical

results in treatment of patients with Chronic Limb Threatening Ischemia (CLTI)

and below-the-knee artery disease. In the PRESTIGE study which was presented as

a late breaking trial at the VIVA 2021 congress by Dr Tjun Tang, use of

SELUTION SLR in complex BTK lesions resulted in sustained safety and efficacy

outcomes out to 18 months. An additional 75 patients with BTK disease and

SELUTION SLR treatment have been studied in the PRISTINE registry and the

results are scheduled to be presented at LINC 2022. Based on the early

promising data following the use of SELUTION SLR in treatment of BTK disease,

MedAlliance has moved forward with the design of the SELUTION4BTK RCT to

further investigate the safety and efficacy of this device and prepare for US

FDA approval.

SELUTION SLR's technology involves unique MicroReservoirs made from

biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These

MicroReservoirs provide controlled and Sustained Limus Release (SLR) of the

drug. Extended release of sirolimus from stents has been demonstrated highly

efficacious in both coronary and peripheral vasculatures. MedAlliance's

proprietary CAT(TM)(Cell Adherent Technology) enables the MicroReservoirs to be

coated onto balloons and adhered to the vessel lumen when delivered via an

angioplasty balloon.

SELUTION SLR is available in Europe and all other countries where the CE Mark

is recognized.

Contact: Richard Kenyon, rkenyon@medalliance.com, +44-7831-569940

Source:  MedAlliance