- New results presented at Cardiovascular Research Technologies
(CRT) 2023 demonstrate the safety of Navitor™ TAVI system and its
effectiveness in minimizing blood leakage around the valve
implant
- Latest data continue to show the benefits of Amplatzer™ Amulet™
LAA Occluder's immediate and complete closure of the LAA compared
to Watchman‡
- Findings underscore the importance of innovative, minimally
invasive treatment options for people battling complex heart
conditions like aortic stenosis and atrial fibrillation
ABBOTT
PARK, Ill., Feb. 28,
2023 /PRNewswire/ -- Abbott (NYSE: ABT) today
announced late-breaking data for its next-generation Navitor™
transcatheter aortic valve implantation (TAVI) system. Results from
the study supported Navitor's recent U.S. Food and Drug
Administration (FDA) approval to treat people with severe,
symptomatic aortic stenosis who are at high or greater risk for
open-heart surgery.
The company also showcased late-breaking data for the Amplatzer™
Amulet™ Left Atrial Appendage (LAA) Occluder that continue to
highlight the benefits of this device's immediate and complete
closure of the LAA – a differentiator from competing therapies –
for patients with atrial fibrillation (AFib) at risk of
stroke.
The results of both studies were presented during late-breaking
presentations at the annual Cardiovascular Research Technologies
(CRT) meeting held in Washington,
D.C. (February 25-28, 2023).
The findings reinforce the importance of continued advancements in
minimally invasive technology that offer hope to patients with
debilitating heart conditions.
New Results Highlight the Benefits of Navitor TAVI
System
Following the development of Abbott's next-generation
TAVI system, the company launched the PORTICO NG (Next Generation)
study; a prospective, multi-center, international, single-arm trial
that supported the recent FDA approval of the Navitor TAVI system.
Navitor features an active sealing cuff to reduce or eliminate the
backflow of blood around the valve (paravalvular leak, or PVL), a
known challenge with early generation TAVI devices. Based on the
results from that study, Navitor was found to be a safe and
effective treatment option for patients with severe, symptomatic
aortic stenosis who are at high or greater surgical risk.
In the PORTICO NG study, Navitor was found to offer:
- High rate of procedural success (97%)
- Low rate of all-cause mortality (1.9%) and disabling stroke
(1.9%) at 30 days
- Excellent PVL results, including 0% moderate or greater PVL at
30 days, demonstrating effectiveness of the NaviSeal™ active
sealing cuff
"Abbott's Navitor device offers a minimally invasive treatment
option for severe aortic stenosis that can be lifesaving," said
Michael Reardon, M.D., Alison Family
Distinguished Chair of Cardiovascular Research and professor of
cardiothoracic surgery at the Houston Methodist Hospital, who
served as principal investigator for the study that led to FDA
approval of Navitor. "The trial provides promising results on
the safety and effectiveness of Navitor in addressing this common
heart valve disease, highlighting a reduction in the backflow of
blood around the valve due to the system's design."
New Findings From the Amulet IDE Study
The Amulet IDE
trial is the largest randomized LAA occlusion study to date,
consisting of more than 1,800 patients. Findings demonstrate 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 seal
off the opening into the LAA) had fewer unresolved, severe
peri-device leaks (PDLs), where blood leaks around the implant,
compared to Boston Scientific's Watchman‡ device that has a
single component to close the LAA. PDLs after LAA occlusion have
been shown to be associated with poor five-year outcomes (ischemic
stroke or systemic embolism).
The new data demonstrated:
- Larger LAA anatomy was a predictor of severe PDL with the
Watchman device whereas there were no anatomical predictors with
the Amplatzer Amulet
- Severe PDLs with the Amulet device were less common and
resolved over time more often than with Watchman
- Severe PDLs with Amulet were less commonly associated with
adverse events and deaths than Watchman
"These results for Navitor and Amulet demonstrate that the
innovative designs of our minimally invasive devices are changing
how doctors are approaching – and patients are experiencing – the
treatment of structural heart conditions," said Michael Dale, senior vice president of Abbott's
structural heart business. "We continue to focus on addressing the
unmet needs of patients with heart disease and advancing standards
of care so people can live their fullest possible lives."
For U.S. important safety information on Navitor, visit
https://abbo.tt/NavitorISI.
For U.S. important safety information on Amulet,
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
115,000 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.
© 2023 Abbott. All Rights Reserved.
View original
content:https://www.prnewswire.com/news-releases/late-breaking-data-reinforce-benefits-of-abbotts-minimally-invasive-heart-devices-301757721.html
SOURCE Abbott