PARIS, May 23, 2018 /PRNewswire/ -- Abbott (NYSE: ABT)
today announced favorable outcomes from the first 100 patients
treated in a global study of its Tendyne Transcatheter Mitral Valve
Replacement (TMVR) system, the first and only mitral replacement
valve that is repositionable and fully retrievable to allow for
more precise implantation, helping improve patient outcomes. The
trial is the largest study of a transcatheter mitral valve
replacement device to date. Results at 30 days demonstrated
that Tendyne is associated with a significant reduction of mitral
regurgitation symptoms and low mortality rates. The data were
presented during a late-breaking session at EuroPCR, the annual
meeting of the European Association of Percutaneous Cardiovascular
Interventions (EAPCI), in Paris.
Mitral regurgitation (MR) is a debilitating, progressive and
life-threatening disease in which the heart's mitral valve does not
close completely, causing blood to flow backward and leak into the
left atrium of the heart. The condition can raise the risk of
irregular heartbeats, stroke and heart failure. Nearly one in 10
people over the age of 75 have moderate to severe MR1,
which is often difficult to diagnose.
Tendyne is a first-of-its-kind device that offers patients with
severe MR a life-saving treatment option, replacing their native
mitral valve without open heart surgery to reduce their heart
failure symptoms. As the first and only repositionable, fully
retrievable and minimally invasive replacement option, Tendyne's
unique features help physicians correctly implant the device for
improved patient outcomes.
"Treating people with severe mitral regurgitation can be
challenging because of advanced age, frailty or other complicating
factors, and alternative treatments to surgery are needed," said
principal investigator David Muller,
MBBS, M.D., St Vincent's Hospital, Sydney, Australia. "These new data on the
Tendyne replacement valve offer early hope for patients who are not
eligible for transcatheter valve repair or surgery to relieve
symptoms."
The global study plans to enroll up to 350 adult patients with
symptomatic MR who are not eligible for open-heart surgery to
repair or replace the mitral valve. The primary endpoints of
the study are safety – defined as device success and freedom from
device- and procedure-related serious adverse events – and
performance assessed by reduction in mitral regurgitation severity.
Left untreated, MR may result in a variety of symptoms, heart
failure, and ultimately death.
In these early results from the study, investigators
successfully implanted the Tendyne system in 97 of the first 100
patients. Treated patients experienced a significant reduction in
mitral regurgitation at 30 days, as well as improvements in
symptoms based on New York Heart Association (NYHA) grade severity
and the Kansas City Cardiomyopathy Questionnaire (KCCQ), important
assessment methods of patients' health status. The KCCQ score is
the standard tool used to assess quality of life in patients with
MR, and improvements were observed in treated patients.
At baseline, 99.0 percent of patients enrolled had a MR grade of
≥ 3+, which at 30 days was reduced to none or trace in 98.7 percent
of patients. Data showed a 97 percent implant success rate with no
associated deaths or strokes. The 30 day results demonstrated low
rates of serious adverse events and low mortality (6 percent
(6/100) vs. 7.9 percent STS-predicted mortality for surgical
valve replacement, or the Society of Thoracic Surgeons score used
to predict long-term survival. This represented a favorable 0.76
(6/7.9) ratio of observed-to-expected mortality, or a measure of
assumed patient deaths due to age or other comorbities beyond a
care team's control.
Tendyne is currently under clinical investigation in
Europe, and Abbott expects to
enroll the first patient in the U.S. pivotal trial in the coming
months. Abbott is a global leader in the treatment of MR with the
MitraClip® device, which has been on the market in the EU since
2008 and in the U.S. since 2013. More than 60,000 patients have
been treated with this first-of-its-kind therapy, a catheter-based,
minimally invasive device that is delivered to the heart through a
blood vessel in the leg.
By securing a portion of the leaflets of the mitral valve with a
clip, the heart can pump blood more efficiently throughout the
body, thereby relieving the symptoms of severe MR and improving
patient quality of life.2 For MR patients who are not
candidates for traditional open-heart surgery or a minimally
invasive mitral valve repair, Tendyne may offer a new valve
replacement treatment option.
"Tendyne was specifically designed to address the functional,
degenerative and mixed causes of mitral regurgitation that cannot
be addressed through minimally invasive valve repair or open-heart
surgery," said Michael Dale, vice
president of Abbott's structural heart business. "As leaders in
transcatheter mitral valve repair, we look forward to advancing
another minimally invasive treatment option with unique benefits
for people with complex structural heart conditions in need of
mitral valve replacement."
For U.S. important safety information on MitraClip, visit
https://mitraclip.com/#isi.
The Tendyne Transcatheter Mitral Valve Replacement system is
an investigational device only.
About Abbott:
At Abbott, we're committed to helping people live their best
possible life through the power of health. For more than 125 years,
we've brought new products and technologies to the world -- in
nutrition, diagnostics, medical devices and branded generic
pharmaceuticals -- that create more possibilities for more people
at all stages of life. Today, 99,000 of us are working to help
people live not just longer, but better, in the more than 150
countries we serve.
Connect with us at www.abbott.com, on Facebook at
www.facebook.com/Abbott and on Twitter @AbbottNews and
@AbbottGlobal.
1 Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS,
Scott CG, Enriquez-Sarano M. Burden
of valvular heart diseases: a population-based study. Lancet. 2006
Sep 16;368(9540):1005-11.
https://www.ncbi.nlm.nih.gov/pubmed/16980116
2
http://www.abbottvascular.com/docs/ifu/structural_heart/eIFU_MitraClip.pdf
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