NYON, Switzerland, July 11,
2020 /PRNewswire/ -- MedAlliance has announced
enrollment of the first patient in its study of SELUTION SLR™ 014
DEB for the treatment of In-Stent Restenosis (ISR). This is
the first DEB accepted by the FDA for its 'Breakthrough Program'.
The SELUTION SLR (Sustained Limus Release) is a novel sirolimus
eluting balloon that provides a controlled sustained release of
drug, similar to a drug-eluting stent (DES).
The objectives of this prospective, randomized, single-blind
multicenter study are to demonstrate the safety and efficacy of
SELUTION SLR in treatment of ISR with either drug-eluting or bare
metal stents (BMS). The study will support submission for FDA
approval.
"This first patient was treated with the investigational device
after suffering a DES ISR. We are delighted to be able to offer our
patients this promising new technology," commented Professor
Pascal Vranckx, Hartcentrum Hasselt,
Belgium. "We are excited to
participate in a study that validates this novel technology for ISR
treatment. SELUTION SLR may provide an additional treatment option
for these patients. We very much look forward to the results of
this study."
Up to 418 subjects will be recruited into the study at
approximately 60 sites across both the US and Europe. Subjects need to have a BMS or DES ISR
involving a native coronary artery with a reference vessel diameter
(RVD) of 2.00 – 4.50 mm to qualify for inclusion. Subjects will be
randomized to receive either SELUTION SLR or Standard of Care (SOC)
– a control group with a current DES or a non-drug eluting balloon
angioplasty.
The primary endpoint for effectiveness of the study is Target
Lesion Failure (TLF): defined as all cardiac death; target vessel
myocardial infarction; or clinically driven Target Lesion
Revascularization (TLR) at 12 months.
Subjects will be followed up at one month, six months, 12 months
and then annually through five years.
"This is a particularly important study for MedAlliance,"
explained Chairman and CEO Jeffrey B.
Jump. "No coronary drug-eluting balloon has yet been
approved in the US, where ISR currently represents 11% of all stent
implantations. We are excited to introduce this breakthrough
technology to help patients around the world."
The Principal Investigator of this study is Donald Cutlip, Professor of Medicine at
Harvard Medical School and Chief
Medical Officer at the Baim Institute for Clinical Research.
Professor Cutlip helped design the study in consultation with the
Institute.
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™ (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 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. It is now is available in
Europe and all other countries
where the CE Mark is recognized. The global market for DEB is
estimated to be $2 Billion.
About MedAlliance
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: http://medalliance.com/
Media Contact:
Richard
Kenyon
rkenyon@medalliance.com
+44-7831-569940
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