PR87831

NYON, Switzerland, January 28, 2021, /PRNewswire=KYODO JBN/--

12-month results from the PRESTIGE* Below-the-Knee (BTK) study have been

presented as a Late Breaking Trial at LINC 2021. The objective of this clinical

investigation has been to evaluate safety and performance outcomes of SELUTION

SLR[TM], MedAlliance's novel sirolimus-eluting balloon, for the treatment of

long tibial occlusive lesions (TASC C & D) in patients with Critical Limb

Ischemia (CLI).

The Primary Patency Rate was 78% and the rate of wound healing was 81%. Freedom

from Target Lesion Revascularization (TLR) was exhibited by 93% of patients and

84% demonstrated Amputation Free Survival (AFS). All these figures have been

sustained from the six-month data.

PRESTIGE is a prospective, single-center, physician-initiated clinical study,

run at the Singapore General Hospital (SGH) by Associate Professor Tze Tec

Chong and Dr. Tjun Yip Tang, who are both Senior Consultants at the Hospital's

Department of Vascular Surgery. Twenty-five patients were enrolled with an

average age of 64. 88% had diabetes mellitus and 44% had end stage renal

failure. No patients required bailout stenting. Clinical follow-up was at one,

three, six and 12 months.

"We have observed minimal slow-flow phenomena and some cases of fast wound

healing with this balloon. It is also easy to track and deliver. We are looking

forward to gaining further clinical experience with this device," commented

Prof. Chong.

CLI is a severe obstruction of the arteries which markedly reduces blood flow

to the extremities. It can progress to the point of severe pain and skin ulcers

or sores: CLI often leads to amputation.

Singapore has a high percentage of diabetics in its population and CLI

therefore constitutes a major challenge among patients seen with Peripheral

Artery Disease (PAD). SGH performs over 1,000 interventional procedures a year

on patients suffering from CLI.

"We are very pleased with the one-year BTK results in this very difficult

patient population", added MedAlliance Chairman and CEO Jeffrey B. Jump. "This

complements the excellent results we have seen in SFA and coronary patients".

In February 2020 MedAlliance received CE Mark approval for SELUTION SLR in the

treatment of peripheral artery disease. Both the STEP Pedal Arch study and

SUCCESS PTA, a large post marketing clinical study in PAD, will commence

enrolment soon. In the US, SELUTION SLR has received US Food and Drug

Administration (FDA) Breakthrough Device Designation Status for a DEB in the

treatment of peripheral below-the-knee lesions.

SELUTION SLR's technology involves unique MicroReservoirs made from

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

MicroReservoirs provide controlled and sustained release of the drug. Extended

release of sirolimus from stents has been proven 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

adhere to the vessel lumen when delivered via an angioplasty balloon.

* Physician initiated, prospective, non-Randomized single-center trial,

investigating the safety and Efficacy of the Treatment with the Selution

Sirolimus Coated Balloon in TASC C and D Tibial occlusive disease In patients

with critical limb Ischemia from SinGaporE.

Media Contact:

Richard Kenyon

rkenyon@medalliance.com

+44 7831 569940

Founded in 2008, MedAlliance is a privately-owned medical technology company.

It is headquartered in Switzerland, with facilities in Irvine, California;

Glasgow, UK; and Singapore. 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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SOURCE: MedAlliance