- Five late-breaking presentations at TCT 2022 highlight the
impact of Abbott's structural heart devices to repair or replace
heart valves and close openings in the heart
- New data reinforce the safety and effectiveness of MitraClip™
for treating mitral regurgitation
- Results also demonstrate the benefits of Abbott's TriClip™ for
tricuspid regurgitation, Amulet™ for stroke reduction in patients
with atrial fibrillation and Portico™ for aortic stenosis
ABBOTT
PARK, Ill., Sept. 17,
2022 /PRNewswire/ -- Abbott (NYSE: ABT) today
announced data from five late-breaking presentations showing the
benefits of its minimally invasive devices in treating people with
a range of structural heart diseases. Data include findings that
reinforce the value of MitraClip™, the world's first and leading
transcatheter edge-to-edge repair (TEER) device, to treat leaky
valves in people with mitral regurgitation (MR).
The new data around Abbott's structural heart therapies were
presented at the 34th Transcatheter Cardiovascular
Therapeutics (TCT) annual scientific symposium of the
Cardiovascular Research Foundation in Boston (September
16-19, 2022). Results were also presented on TriClip™, the
first therapy designed specifically for tricuspid heart valve
repair; the Amplatzer™ Amulet™ Left Atrial Appendage Occluder, a
minimally invasive option offering the most complete closure of the
left atrial appendage (LAA) to reduce risk of stroke; and Portico™,
a self-expanding transcatheter aortic valve implantation (TAVI)
system.
Structural heart diseases such as valve disease or openings in
the heart that require closure can impair how the heart moves blood
through the body. New minimally invasive technology has changed how
physicians approach patient care and limits the need for more
complex or risky surgery.
MitraClip EXPAND G4 Post-Approval Study
Data presented from the prospective, multi-center, global
real-world EXPAND G4 study support the safety and effectiveness of
the MitraClip G4 system for treating MR. The study represents the
largest report of 30-day core lab-assessed outcomes, which included
more than 1,000 patients. The data confirm that MitraClip offers
high success rates in terms of MR reduction, improvements in
quality of life and low adverse event rates.
Key findings through 30 days include:
- Significant MR reduction to mild or less (≤ grade 1+ on a
four-point scale) is achieved in 91% of patients, with lowest
reported adverse event rates to date (1.3% all-cause mortality at
30 days)
- Clinical improvements including 83% of patients achieving New
York Heart Association (NYHA) Functional Class I/II (a
classification of functional limitations resulting from cardiac
disease, with Class I/II meaning slight or no limitation of
physical activity), an improvement of 52% from baseline of 31%; and
an 18-point improvement in the Kansas City Cardiomyopathy
Questionnaire (KCCQ) score (a self-assessment of social abilities,
symptoms and quality of life), a 35% improvement from baseline
score
- Multiple clip sizes enable tailoring the therapy to patients'
mitral valve anatomy and expand the spectrum of TEER-suitable
patients
"MitraClip therapy has fundamentally changed the way doctors
treat mitral regurgitation, provides a valuable therapy option that
does not require open-heart surgery, and goes beyond simply
managing symptoms with medications," said Jason Rogers, M.D., professor of cardiovascular
medicine and director of interventional cardiology and structural
heart training programs at the University of
California, Davis Medical Center. "These late-breaking data
demonstrate and strengthen the evidence that Abbott's MitraClip
system consistently reduces MR in a broad range of patients, while
restoring proper function of the mitral valve and improving
patients' quality of life."
The MitraClip system has been commercially available in the U.S.
since 2013 and in Europe since 2008. With more than
150,000 patients treated worldwide, MitraClip is approved in more
than 75 countries, spanning regions in Asia, Africa,
Europe, the Americas and
Australia.
"These results add to what's been proven through nearly two
decades of clinical experience in transcatheter mitral repair –
MitraClip provides long-term, significant mitral regurgitation
reduction that changes and saves lives," said Michael Dale,
senior vice president of Abbott's structural heart business.
"Abbott was the first to offer a transcatheter mitral valve repair
device that provides a minimally invasive treatment option for
patients with MR who would otherwise go untreated, and we remain
committed to addressing the unmet needs of people with structural
heart conditions."
First Results from the TriClip TRILUMINATE Pivotal
Trial
TRILUMINATE Pivotal is the first randomized,
controlled clinical trial evaluating the safety and effectiveness
of TEER with TriClip in 700 patients with severe TR in the U.S.,
Canada and Europe. The data from the roll-in cohort
through 30 days show:
- High implant success rate (99%)
- At least a one-grade TR reduction in 91% of patients, with
moderate or less residual TR achieved in 74%
- Patients achieving around a 17-point improvement in the KCCQ
score, a 30% improvement from baseline score, which demonstrates a
substantial improvement in their quality of life
Three-Year Outcomes from the Amulet IDE Study
The
Amplatzer Amulet LAA Occluder with dual-seal technology (consisting
of a lobe or piece to fill the cavity of the LAA and a disc to
close off the opening into the LAA) is the first and only minimally
invasive treatment option to offer immediate and complete
dual-sealing closure of the LAA, reducing the risk of stroke and
eliminating the need for blood-thinning medication. The
prospective, international, multi-center Amulet IDE trial is the
largest randomized LAA occlusion study to date consisting of more
than 1,800 patients, and three-year outcomes demonstrate the safety
and effectiveness of Amulet, with data showing:
- Device-related factors (device-related thrombosis or
peri-device leak) more frequently preceded strokes in patients with
Boston Scientific's Watchman‡ than those with Amulet
- Both cardiovascular and all-cause death trended higher in the
Watchman device than the Amulet device
PREDICT-LAA Trial (Amulet)
Data were also presented
from the PREDICT-LAA prospective, multi-center, randomized
controlled trial that studied if the use of cardiac computed
tomography-based computational models (high-resolution scans of
patients' hearts generated by FEops HEARTguide‡) help in the
planning of Amplatzer Amulet procedures. Key findings at three
months include:
- Improved procedural efficiency and safety outcomes with the
Amplatzer Amulet LAA Occluder were achieved when planned with
HEARTguide
Portico CONFIDENCE Registry
The CONFIDENCE Registry is
an international, prospective, real-world study evaluating the
safety and effectiveness of the Portico TAVI valve using the
first-generation Portico delivery system in 501 patients and the
second-generation FlexNav™ delivery system in 500 patients.
Late-breaking data on valve hemodynamics (blood flow) at 30 days
and one-year survival following implantation of the Portico TAVI
device will be presented at TCT on Sunday,
Sept. 18
For U.S. important safety information on MitraClip,
visit http://abbo.tt/MitraClipG4ISI.
For U.S. important safety information on Amulet,
visit https://abbo.tt/AmuletISI.
For U.S. important safety information on Portico,
visit https://abbo.tt/PorticoISI.
The TriClip Transcatheter Tricuspid Valve Repair System is an
investigational device 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
113,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn
at www.linkedin.com/company/abbott-/, on Facebook
at www.facebook.com/Abbott and on Twitter
@AbbottNews.
™ Indicates a trademark of the Abbott group of companies.
‡ Indicates a third-party trademark, which is property of its
respective owner.
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SOURCE Abbott