OR YEHUDA, Israel, Sept. 19, 2015 /PRNewswire/ -- Valtech
Cardio, Ltd., an innovator in the development of devices for mitral
and tricuspid valve repair and replacement, announces it has
received Conformité Européenne (CE) Marking for its
Cardioband® Mitral Reconstruction System, (Cardioband),
a proprietary implantable mitral reconstruction device with a
transfemoral transseptal delivery system for mitral valve repair.
The designation was based on the results of a multicenter
feasibility trial that demonstrated the safety and effectiveness of
Cardioband in mitral valve repair and will allow Valtech to market
and sell Cardioband in the European Union. Valtech will officially
unveil the Cardioband at the upcoming PCR London Valves meeting,
being held September 20 to 22, 2015,
in Berlin, Germany.
"This is a significant milestone for Valtech and one we feel
will add significantly to the ability of physicians to address a
condition that is a major contributor to congestive heart failure,"
said Amir Gross, founder and CEO of
Valtech Cardio. "The Cardioband was specifically designed to
facilitate mitral valve repair in a first-line setting while
preserving the ability to perform future percutaneous or surgical
valve repair and/or replacement, and the results of our multicenter
clinical trial really help to demonstrate the success of this
device in this indication."
Mitral regurgitation (MR) is a vastly underserved condition in
which the mitral valve leaflets fail to close properly, allowing
backflow of blood from the left ventricle into the left atrium
during systole. Left untreated, severe MR can eventually lead to a
meaningful deterioration in cardiac function and, eventually,
death. Approximately 4.2 million patients in the U.S. alone are
affected by mitral valve disease, which represents a
several-billion-dollar global market opportunity.
The Cardioband Mitral Reconstruction System enables
surgical-like repair of the mitral valve annulus via a
transfemoral, transseptal delivery system, allowing for real-time
adjustment on a beating heart. The transcatheter, supra-annular
approach does not interfere with the mitral valve leaflets or
chordae, and does not preclude subsequent treatment options if they
become necessary.
In the multicenter feasibility trial including over 50 patients,
Cardioband was shown to significantly reduce annular size, with
significant improvement in MR. After 6 months of follow up, 82% of
patients (n = 22) were categorized in NYHA Class I-II, with
significant improvement of quality of life (Minnesota Living With
Heart Failure Questionnaire) score of 38 to 18 [p<0.05];
and had six-minute walk test score of 250 to 322 [p<0.05]). At
12 months' follow-up, 94% of patients (n=17) had sustained MR ≤
2+.
"Cardioband is a major step forward in the history of mitral
valve disease and treatment," said Professor Karl-Heinz Kuck,
M.D., Ph.D., Head of Cardiology Department, Asklepios Klinik
St. Georg, Hamburg, Germany. "The
overall experience with Cardioband therapy is extremely satisfying.
We were able to use the technology with all of the patients in the
clinical study without a single failure. I really believe that this
is the very first technology that can be applied systematically
around the world to patients suffering from secondary mitral
regurgitation. For me the Cardioband is the only technology that
can reproducibly reduce the septo-lateral diameter."
Valtech is planning several events at the London Valves meeting
including presentations of clinical data with the Cardioband. On
Monday, September 21, at 15:13, Room
4, Prof. Kuck will present the "Percutaneous Annuloplasty for
Mitral Valve Repair Multicentre Trial Report."
Additional information about Cardioband, including clinical
insights from leading experts in the mitral space, will be
presented during a special Valtech sponsored session titled
"Cardioband: A New Era of Mitral Valve Repair," being held
Tuesday, September 22, Room 2, from
13:00-14:40.
Valtech, which will have a presence at the London Valves meeting
at Booth #1, will be holding a training village located at Level 3
room R13. Interested surgeons are encouraged to stop by the booth
for additional information.
The company will also sponsor a reception in the Exhibition Hall
on Monday, September 21, starting at
18:30.
Cardioband Mitral Reconstruction System
The
Cardioband System combines a reconstruction implant, similar to the
surgical annuloplasty devices, with a transfemoral transseptal
delivery system. Connection of the implant to the mitral annulus is
sutureless using specially designed anchors. Reshaping of the
mitral annulus to eliminate Mitral Regurgitation (MR) is done under
physiological conditions and echocardiographic guidance for optimal
results. Cardioband received CE Mark approval after clinical trial
results demonstrated the device is a safe and efficacious
intervention option for patients with functional mitral
regurgitation (FMR).
About Valtech Cardio, Ltd.
Valtech Cardio, Ltd.,
founded in 2005, is a privately held company specializing in the
development of devices for mitral and tricuspid valve repair and
replacement. Valtech Cardio has full in-house development,
manufacturing, and clinical research capabilities, and over 130
patents and patent applications. The company, comprised of
multidisciplinary development teams, works in close collaboration
with world-renowned heart specialists to provide the best possible
therapy for mitral patients. Funded in part from investments made
by HeartWare International, Inc. (Nasdaq: HTWR) and other private
investors, Valtech Cardio, Ltd., is headquartered in Or Yehuda,
Israel. For more information, visit the company's
website: www.valtechcardio.com.
For additional
Valtech information:
|
Media Contact for
Valtech:
|
Amir
Gross
|
Jessica
Griffith
|
CEO and Founder,
Valtech Cardio
|
Pascale
Communications, LLC
|
Phone:
+972.3.5335959
|
+1.610.618.0013
|
Email:
amir@valtechcardio.com
|
Jessica@pascalecommunications.com
|
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SOURCE Valtech Cardio, Ltd.