- Panel of independent experts reviewed data from
the TRILUMINATE™ pivotal trial demonstrating safety,
effectiveness and quality-of-life benefits of the TriClip
system
- An investigational device in the U.S., TriClip is approved
in more than 50 countries and has treated more than 10,000 people
with tricuspid regurgitation worldwide
ABBOTT
PARK, Ill., Feb. 13,
2024 /PRNewswire/ -- Abbott (NYSE: ABT) today
announced that the Circulatory System Devices Panel of the Medical
Devices Advisory Committee for the U.S. Food and Drug
Administration (FDA) confirmed 13 to 1, with 0 abstention that the
benefits of Abbott's TriClip™ transcatheter edge-to-edge repair
(TEER) system outweighed the risks for the treatment of people with
tricuspid regurgitation (TR). The panel's decision was based on
clinical data from the TRILUMINATE™ pivotal trial, as well as
expert testimony. The panel's vote will be considered by the FDA
when making a decision regarding the approval of TriClip, a
first-of-its-kind minimally invasive device specifically designed
to treat the difficult-to-access tricuspid valve.
"Tricuspid regurgitation can put added strain on the heart and
lead to other cardiovascular issues, which can significantly worsen
a person's quality of life, but historically there have been few
treatment options," said Lars Søndergaard, M.D., chief medical
officer and divisional vice president of medical affairs of
Abbott's structural heart business. "Abbott recognized the unmet
need for people with this condition and explored the use of our
proven clip-based technology to find a truly life-changing
intervention. TriClip offers an urgently needed alternative that is
safe and effective for people who require tricuspid valve repair
but are not able to withstand surgery."
The tricuspid valve controls blood as it flows from the heart's
right atrium to the right ventricle. TR occurs when the valve
doesn't close properly, causing a leak and allowing blood to flow
backward in the heart. For those who continue to have symptoms or
persistent TR despite treatment with medical therapy and are not
considered good candidates for surgery, TriClip represents a
potentially new option that can improve a person's quality of life.
Delivered through a vein in the leg, TriClip's TEER technology
works by clipping together a portion of the leaflets – or flaps of
tissue – to repair the tricuspid valve and help blood flow in the
right direction without the need for open-heart surgery.
After reviewing data from Abbott's TRILUMINATE pivotal trial and
listening to testimony, the panel voted on the device's safety,
effectiveness and risk/benefit profile as a treatment for TR. On
the question of whether there is enough data to support the safety
of the device, the vote was 14 to 0 in favor. On the separate
question of whether there is reasonable assurance that the device
is effective, the vote was 12 to 2 in favor. On the final question
of the benefit of TriClip versus the risk, the vote was 13 to 1 in
favor.
"Tricuspid regurgitation can cause fatigue, shortness of breath,
irregular heart rhythms, swelling and organ dysfunction. As the
disease progresses, it is often debilitating and impacts a person's
ability to live the life they want," said David Adams, M.D., chairman of the department of
cardiovascular surgery at the Icahn School of Medicine at Mount
Sinai and cardiac surgeon-in-chief of the Mount Sinai Health
System, who served as co-principal investigator of the TRILUMINATE
pivotal trial. "In the TRILUMINATE pivotal trial, we found that 90%
of people who received tricuspid valve repair with the TriClip
implant experienced a marked improvement in the severity of their
TR with unprecedented procedural safety, and their improvement in
quality of life was sustained at one year. The TriClip system
ushers in a new era of structural therapy for patients suffering
from severe tricuspid valve disease."
Abbott submitted its pre-market approval (PMA) application for
the TriClip device in March 2023 to
the FDA, which lead to today's advisory committee panel for expert
advice on the device's clinical safety, effectiveness, risk and
benefit. The FDA routinely seeks input from advisory committees,
especially for first-of-a-kind medical devices. The FDA's decision
on Abbott's TriClip is expected in 2024.
TriClip is approved for use in more than 50 countries, including
in Europe and Canada, and has already been used to treat
more than 10,000 people with TR. It is an investigational device in
the United States.
Abbott offers the industry's most comprehensive portfolio of
structural heart solutions. In addition to TriClip, the company's
innovative, minimally invasive therapies include first-of-its-kind
technologies MitraClip™ (to treat leaky valves in people with
mitral regurgitation) and Amplatzer Piccolo™ Occluder (to close a
hole in the heart of babies), as well as the Navitor™ transcatheter
aortic valve implantation system (to treat aortic stenosis). Abbott
continues to focus on addressing the unmet needs of patients with
structural heart disease and advancing standards of care so people
can live their fullest possible lives.
For U.S. important safety information on MitraClip,
visit https://abbo.tt/MitraClipISI.
For U.S. important safety information on the Amplatzer Piccolo
Occluder, visit https://abbo.tt/PiccoloISI.
For U.S. important safety information on Navitor,
visit https://abbo.tt/NavitorISI.
About the Abbott TRILUMINATE Pivotal Trial
The
TRILUMINATE pivotal trial is the world's first randomized,
controlled clinical trial evaluating the safety and effectiveness
of transcatheter repair with the TriClip system compared to medical
therapy in people with symptomatic severe TR who are at
intermediate or greater risk for open-heart surgery. Data
presented at the 35th Transcatheter
Cardiovascular Therapeutics (TCT) annual scientific symposium of
the Cardiovascular Research Foundation in October 2023 for all randomized patients (N=572)
and those enrolled in the concurrent single-arm group (patients
with more complex tricuspid valve anatomy) illustrated the device's
safety, effectiveness and benefits.
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 114,000
colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com and on LinkedIn,
Facebook, Instagram, X and YouTube.
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SOURCE Abbott