ABBOTT PARK, Ill., April 8, 2021
/PRNewswire/ -- Abbott (NYSE: ABT) today announced it has
received CE Mark for its next-generation TriClip™ Transcatheter
Tricuspid Valve Repair System, the first-of-its-kind minimally
invasive tricuspid heart valve repair device available in
Europe to treat tricuspid
regurgitation (TR). The clip-based therapy, known as TriClip G4, is
a non-surgical heart valve repair option specifically designed for
the treatment of TR, or a leaky tricuspid valve, that allows
physicians to tailor repair of the valve to each patient's unique
anatomy.
Often referred to as the "forgotten valve" because of
historically limited treatment options, the tricuspid valve has
three leaflets that control the flow of blood between the two
chambers on the right side of the heart (right ventricle and right
atrium). When those leaflets do not close properly, blood can flow
in the reverse direction – known as regurgitation – forcing the
heart to work harder. The condition typically impacts older
individuals who have multiple co-morbidities, making open-heart
surgery a high-risk procedure and resulting in many people going
untreated. When left unaddressed, TR can lead to debilitating
conditions such as atrial fibrillation (AF), heart failure and,
ultimately, death.1
"Since its initial CE Mark in April
2020, TriClip has emerged as a much-needed treatment option,
offering physicians the opportunity to dramatically improve the
quality of life for people in Europe with severe, symptomatic tricuspid
regurgitation who are not responding to medical therapy and are
often so ill they cannot undergo surgery," said Philipp Lurz, M.D., Ph.D., professor and deputy
head of cardiology, Heart Center Leipzig, University of
Leipzig, Leipzig, Germany. "This newest generation
device further improves cardiologists' ability to safely and
effectively repair the tricuspid valve, which historically has been
extremely challenging to treat."
Leveraging Abbott's technology and robust body of evidence from
the company's leading MitraClip™ device – the safe, effective and
minimally invasive option to repair leaky mitral valves (or mitral
regurgitation) – TriClip was specifically designed to treat the
tricuspid valve's complex anatomy. With a precise and stable
delivery system engineered for navigating the right side of the
heart, TriClip offers physicians new options for treating
debilitating TR.
Recent data for TriClip from the TRILUMINATE CE Mark
study showed sustained symptomatic improvement, reduction in
the severity of TR and improvement in functional
status, demonstrating the benefits of the therapy and
ultimately proving TriClip as a safe and durable treatment
option for high-risk patients with symptomatic moderate or greater
TR.
TriClip is delivered to the heart via a catheter inserted
through the femoral vein in the leg and works by clipping together
a portion of the leaflets of the tricuspid valve to reduce the
backflow of blood. With its differentiated delivery system designed
specifically for the tricuspid valve and a steerable guiding
catheter system, physicians can independently grasp and effectively
clip leaflets of the tricuspid valve to reduce the regurgitation.
This latest innovation includes two new clip sizes, offering
clinicians a total of four sizes to tailor the device to different
patient anatomies.
"Tricuspid regurgitation is considered the most undertreated
valve issue and our newest generation device to address it is the
result of our unwavering commitment to restore health and improve
the quality of life for patients with structural heart disease,"
said Mike Dale, senior vice
president of Abbott's structural heart business. "Our novel TriClip
therapy offers the best possible outcomes for people suffering from
a debilitating condition and gives doctors even more options for
customizing repair of this complex anatomy."
TriClip G4 also recently received Health Canada approval,
broadening its access to more people with TR across the world.
For more information on TriClip, please visit:
http://abbo.tt/TriClip.
For U.S. important safety information on
MitraClip, visit http://abbo.tt/MitraClipG4ISI.
The TriClip and TriClip G4 Transcatheter Tricuspid Valve Repair
Systems are approved for investigational use only in the U.S.
About Abbott:
Abbott is a global healthcare leader
that helps people live more fully at all stages of life. Our
portfolio of life-changing technologies spans the spectrum of
healthcare, with leading businesses and products in diagnostics,
medical devices, nutritionals and branded generic medicines. Our
109,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn
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@AbbottNews.
1 Topilsky, et al JACC Cardiovascular Imaging
2018.
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SOURCE Abbott