MedAlliance announces completion of enrollment in Japanese SELUTION SLR(TM) Study
PR91848
GENEVA, Sept. 23, 2021 /PRNewswire=KYODO JBN/ --
MedAlliance, with its Japanese partner MDK Medical, has completed
enrollment in the clinical study of its novel Sirolimus Drug Eluting Balloon
(DEB), SELUTION SLR(TM), for the treatment of peripheral arterial disease
(PAD). This follows the acceptance of a Clinical Trial Notification (CTN) by
Japan's Pharmaceutical and Medical Device Agency (PMDA) in June 2020.
The study involves 133 patients across 13 centres in Japan. Its objective
is to assess the safety and efficacy of SELUTION SLR for the treatment of
lesions of superficial femoral arteries and/or popliteal arteries. The study is
a prospective, controlled, multi-centre, open, single-arm clinical
investigation. Its primary endpoint is the primary patency rate at twelve
months. Secondary endpoints include Major Adverse Events/TLR, Primary Patency,
and the change of Rutherford classification/ABI/WIQ.
"We are extremely pleased with the regulatory and quality expertise
demonstrated by our partner MDK, and particularly proud that Japanese patients
can now benefit from our unique technology. This is the first sirolimus drug
eluting balloon implanted in Japan, where the current paclitaxel coated balloon
market generates more than $100M in revenue per year," commented MedAlliance
Chairman and CEO Jeffrey B. Jump.
SELUTION SLR was awarded CE Mark Approval for the treatment of peripheral
artery disease in February 2020 and for the treatment of coronary arterial
disease in May 2020. The US FDA has awarded SELUTION SLR with four breakthrough
designations: for the treatment of atherosclerotic lesions in native coronary
arteries; coronary in-stent restenosis; peripheral below-the-knee and
AV-Fistula indications.
In August 2021, the first of over 3,000 patients was enrolled in a
ground-breaking coronary randomized controlled study comparing SELUTION SLR
with a limus drug-eluting stent [DES]. This is the largest DEB study ever
initiated and has the potential to change medical practice.
MedAlliance's DEB 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 for up to
90 days1. Extended release of sirolimus from stents has been proven highly
efficacious in both coronary and peripheral vasculatures. MedAlliance's
proprietary CA(TM) (Cell Adherent Technology) enables the MicroReservoirs to be
coated onto balloons and adhere to the vessel lumen when delivered via an
angioplasty balloon.
Media Contact:
Richard Kenyon
rkenyon@medalliance.com
+44 7831 569940
About MedAlliance
MedAlliance is a privately-owned medical technology company. It is
headquartered in Nyon, Switzerland, with offices in Germany, Singapore, UK and
USA. 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
1. Drug concentration evident in MicroReservoirs and tissue – Data on file
at M.A. Med Alliance SA
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Photo:
https://mma.prnewswire.com/media/1631888/MedAlliance_Selution_SLR.jpg
Source: MedAlliance
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