- TriClip offers a remarkably safe, minimally invasive treatment
option for patients in need of tricuspid valve repair but who are
unable to withstand surgery
- More than 1.6 million people in the U.S. are affected by
tricuspid regurgitation,1 which can severely impact
quality of life
- Data from the TRILUMINATE™ Pivotal trial demonstrated that
patients who received TriClip experienced a marked improvement in
the severity of their symptoms and quality of life, with benefits
sustained at one year
ABBOTT
PARK, Ill., April 2,
2024 /PRNewswire/ -- Abbott (NYSE: ABT) today
announced that the U.S. Food and Drug Administration (FDA) has
approved the company's first-of-its-kind TriClip™
transcatheter edge-to-edge repair (TEER) system that's specifically
designed for the treatment of tricuspid regurgitation (TR), or a
leaky tricuspid valve. This approval follows the recent
recommendation of the Circulatory System Devices Panel of the
Medical Devices Advisory Committee for the FDA, whose vote
confirmed 13 to 1, with 0 abstention that the benefits of TriClip
outweighed the risks.
Experience the full interactive Multichannel News Release here:
https://www.multivu.com/players/English/9255151-abbott-receives-fda-approval-for-triclip-device-to-repair-leaky-tricuspid-heart-valve/
"The U.S. approval of TriClip is a significant advancement for
people suffering from tricuspid regurgitation, a heart condition
that negatively impacts their quality of life and puts them at
grave risk of serious health issues," said Paul Sorajja, M.D., the Roger L. and Lynn
C. Headrick Family Chair of the Valve Science Center for the
Minneapolis Heart Institute Foundation and director of the Center
for Valve and Structural Heart Disease for the Minneapolis Heart
Institute at Abbott Northwestern Hospital and co-principal
investigator of the TRILUMINATE™ Pivotal trial. "With TriClip,
physicians can offer patients a therapy option backed by excellent
safety and effectiveness to help restore tricuspid native valve
performance without subjecting them to high-risk open-heart surgery
that may not be feasible for individuals with TR who are generally
older and sicker."
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. TR can force the heart to work harder,
causing debilitating symptoms such as fatigue and shortness of
breath. When left untreated, TR can lead to atrial
fibrillation, heart failure, and ultimately, death. 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 an 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. On average, people who receive TriClip only need one day
in the hospital before they recover and can return home.
As part of its approval process, the FDA reviewed findings from
the TRILUMINATE Pivotal trial, the world's first randomized,
controlled clinical study to evaluate the safety and effectiveness
of the TriClip system compared to medical therapy in people with
severe TR who are at intermediate or greater risk for open-heart
surgery. In the study, 90% of patients who received the TriClip
system experienced a marked improvement in their TR grade, reducing
from severe or higher to moderate or less at 30 days – a reduction
that was sustained at one year. The trial also demonstrated a
highly favorable safety profile, with 98% of patients being free of
major adverse events through 30 days, and a significant improvement
in quality of life.
"This approval helps address a treatment gap for people with
tricuspid regurgitation who previously had few options to treat a
disease that adversely impacted their daily lives and could lead to
other deadly conditions," said Sandra Lesenfants, senior vice
president of Abbott's structural heart business. "With the addition
of TriClip to our broad structural heart therapy offerings in the
U.S., we are continuing to bring meaningful, life-enhancing
benefits to patients with cardiovascular conditions."
TriClip leverages the same clip-based technology as Abbott's
leading MitraClip™ device – which has treated more than 200,000
people with leaky mitral valves (mitral regurgitation) – but was
specifically designed to treat the tricuspid valve's complex
anatomy.
TriClip has been approved for use in more than 50 countries,
including in Europe and Canada, since its initial CE Mark
approval in 2020. The device has already been used to treat more
than 10,000 people with TR.
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 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 TriClip,
visit https://abbo.tt/TriClip_ISI.
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 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.
|
|
|
|
|
|
|
|
|
1 Kolte, Dhaval & Elmariah,
Sammy. (2020). Current state of transcatheter tricuspid valve
repair. Cardiovascular Diagnosis and Therapy. 10. 89-97.
10.21037/cdt.2019.09.11.
|
View original
content:https://www.prnewswire.com/news-releases/abbott-receives-fda-approval-for-triclip-first-of-its-kind-device-to-repair-leaky-tricuspid-heart-valve-302105177.html
SOURCE Abbott