- Data presented at EuroPCR 2022 reinforce the impact of Abbott's
minimally invasive heart devices on patient outcomes and quality of
life
- Findings demonstrate TriClip™ transcatheter edge-to-edge (TEER)
repair is effective at reducing tricuspid regurgitation across a
broad range of anatomies
- One-year outcomes for Navitor™ transcatheter aortic valve
implantation (TAVI) system show the safety and effectiveness of
this therapy and durable performance of the sealing cuff in
minimizing paravalvular leak for patients with severe aortic
stenosis
ABBOTT PARK, Ill., May 19, 2022
/PRNewswire/ -- Abbott (NYSE: ABT) today announced two
late-breaking data presentations highlighting both TriClip™, a
first-of-its kind minimally invasive tricuspid heart valve repair
device, and Navitor™, the company's latest-generation transcatheter
aortic valve implantation (TAVI) system. The company also showcased
new data for MitraClip™ and Amplatzer™ Amulet™, two key components
of the company's industry-leading structural heart portfolio.
All data were presented at EuroPCR, the annual meeting of the
European Association of Percutaneous Cardiovascular Interventions,
held in Paris from May 17-20, 2022.
30-Day Results from the TriClip bRIGHT Study
New real-world outcomes highlighted in a late-breaking data
presentation showed that the TriClip and TriClip G4 transcatheter
edge-to-edge repair (TEER) systems significantly reduce tricuspid
regurgitation (TR) and substantially improve quality of life across
a wide range of anatomically diverse patients, with data through 30
days showing:
- High implant success rate (98%)
- Significant TR reduction (71% moderate or less compared to 3%
as baseline) with a strong safety profile (99% freedom from major
adverse events)
- Life-changing clinical improvements including 78% of patients
achieving New York Heart Association (NYHA) Functional Class I/II
(a classification of functional limitations resulting from cardiac
disease), an improvement by 57% from baseline of 21%, and an
18-point improvement in the Kansas City Cardiomyopathy
Questionnaire (KCCQ) score (a self-assessment of social abilities,
symptoms and quality of life)
"Historically, people suffering from severe tricuspid
regurgitation had extremely limited treatment options despite being
very ill. Many were ineligible for surgery and were limited to
symptom management," said Philipp
Lurz, M.D., Ph.D., professor and deputy head of cardiology,
Heart Center Leipzig at University of Leipzig, Leipzig,
Germany. "The late-breaking data
show a high rate of implant success and significant reduction in
regurgitation. Transcatheter edge-to-edge repair using TriClip has
a huge potential to improve patients' quality of life and
has entered the clinical stage with widespread use in Europe."
One-Year Results from Study on the Next-Generation Navitor
TAVI System
Data from the multi-center, international, single arm
study of the Navitor TAVI system with an active sealing cuff
to minimize paravalvular leak (PVL) demonstrated improved
one-year outcomes for patients with severe, symptomatic aortic
stenosis who were at high or extreme surgical risk. Key findings
include:
- High procedural success rate of 97.5%
- High rate of no/trace PVL (70.2%) and low rate of mild PVL
(28.8%) through one year, indicating the active sealing cuff is
effective in mitigating PVL
- Low rate of all-cause mortality (4.2%) at one year
- Single-digit gradients (average 7.5 mmHg) through one year
"Patients with symptomatic, severe aortic stenosis are often at
high risk of complications from open-heart surgery due to their old
age, frailty or having multiple other diseases and conditions,"
said Dave Smith, M.D, professor and
consultant cardiologist, Morriston Hospital, Swansea, Wales. "The one-year results from the
study demonstrate that a minimally invasive TAVI procedure with a
Navitor valve offers a safe and effective treatment option for
these patients."
Other data sets presented at EuroPCR included positive findings
from the EXPAND study which showed MitraClip therapy in heart
failure patients with mitral regurgitation experience improved
symptoms and quality of life. Additionally, although women have
higher rates of early complications with LAA closure than men,
results from the Amulet IDE trial found that both women and men
implanted with Abbott's Amplatzer Amulet Left Atrial Appendage
(LAA) Occluder experienced similar long-term benefits from LAA
closure.
"At Abbott, we're dedicated to delivering innovative
technologies to help people with debilitating heart conditions live
better lives through better health," said Michael Dale, senior vice president of Abbott's
structural heart business. "The data presented during this
year's EuroPCR meeting underscore our unwavering commitment to
providing structural heart solutions, supported by clinical
evidence, that surpass existing standards of care."
The TriClip Transcatheter Tricuspid Valve Repair System and
Navitor Transcatheter Aortic Valve are approved for investigational
use only in the U.S.
For U.S. important safety information on MitraClip,
visit http://abbo.tt/MitraClipG4ISI.
For U.S. important safety information on the Amplatzer Amulet
LAA Occluder, visit https://abbo.tt/AmuletISI.
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.
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