ABBOTT PARK, Ill., June 25, 2020
/PRNewswire/ -- Abbott (NYSE: ABT) today announced late-breaking
data on a number of its life-changing products to treat people with
structural heart diseases. The data included findings on the
MitraClip™ system for transcatheter mitral valve repair and data on
two first-in-the-world devices approved in the EU: the TriClip™
system* for transcatheter tricuspid valve repair and the Tendyne™
transcatheter mitral valve implantation system* for people needing
a replacement mitral valve.
Clinical and real-world evidence show that transcatheter devices
can dramatically change the treatment approaches for complex
cardiac conditions. The body of data spanning these technologies
show continued positive outcomes for less invasive transcatheter
therapies and emphasize Abbott's commitment to advancing new
treatment options for people with mitral regurgitation (MR) and
tricuspid regurgitation (TR).
The new late-breaking data on Abbott's transcatheter structural
heart therapies will be presented as part of a virtual three-day
PCR e-Course held by the European Association of Percutaneous
Cardiovascular Interventions (EAPCI), June
25-27.
Treating Mitral Regurgitation with Repair and
Replacement
One of the most common types of heart valve
diseases, MR affects nearly one in 10 people over the age of 75,
and is a condition in which the flaps, or leaflets, of the mitral
valve do not close properly, allowing blood to flow backward into
the heart. The disease can cause debilitating and sometimes fatal
symptoms, yet people with MR are often not eligible for the
standard-of-care open-heart surgery because of their age, frailty,
comorbidities or other complicating factors. New data presented at
the PCR e-Course demonstrate:
- MitraClip is confirmed to have leading safety and
effectiveness in the largest dataset yet. Real-world outcomes
from four separate analyses of the global EXPAND study showed
significant MR reduction (to ≤1+ in 87.1% of patients at 30 days
for primary MR and 90.1% in patients with secondary MR) was
consistently achieved with Abbott's MitraClip NTR/XTR systems in
patients with either primary or secondary MR. The EXPAND study is
the largest contemporary investigation of real-world MitraClip
outcomes studying more than 1,000 patients who received Abbott's
third-generation device, MitraClip NTR/XTR, at 57 sites
worldwide.
- Tendyne, the world's first transcatheter mitral valve
replacement device, provides long-lasting severe MR symptom relief
at two-year follow-up. Clinical outcomes from an analysis of
100 patients with symptomatic, moderate-to-severe or severe MR
treated in the EU Clinical Study of the Tendyne Mitral Valve System
– a first-to-world minimally invasive mitral valve replacement
device recently approved for use in the EU – demonstrated
durability of MR elimination in 93.2% of patients and significant
improvements in quality of life and functional capacity at two
years. This study data supports the valve as a safe treatment
option that provides symptom relief and improved quality of life
for people with symptomatic MR who are not eligible for open-heart
surgery or transcatheter mitral valve repair.
"Historically, people who were ineligible for standard-of-care
surgeries to treat their mitral or tricuspid regurgitation were
limited to symptom management, which does not address the
underlying condition," 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. "These devices treat extremely
complex valve diseases that are debilitating and progress to very
serious conditions when left untreated. The late-breaking data show
significant and consistent reduction in regurgitation, allowing the
heart valve to function as it is intended."
Driving New Treatment Options for Tricuspid Regurgitation
with TriClip
Tricuspid valve regurgitation occurs when the
valve between the two right chambers (right ventricle and right
atrium) of the heart don't close, allowing blood to flow backwards
into the right atrium of the heart. For people with TR, surgery has
traditionally been the only treatment option available but is
rarely performed due to its complexity and risks.
Building on the proven success of MitraClip's clip-based
technology to combat regurgitation, data from the TRILUMINATE CE
Mark study evaluating TriClip, the first minimally invasive,
clip-based tricuspid valve repair device approved in the EU, shows
the impact of the therapy for patients suffering from TR in 85
patients across 21 sites in Europe
and the United States.
New late-breaking trial data with longer term follow-up
(one-year) showed:
- Sustained TR Reduction with TriClip. TRILUMINATE data
showed strong TR reduction in 87.1% of patients who received
Abbott's TriClip and a low all-cause mortality rate of 7.1% at one
year.
- Positive impact of right ventricular function. The study
also showed sustained improvements in right heart function
demonstrating the benefits of tricuspid valve treatment.
- The safety and durability of TriClip performance. By
meeting the TRILUMINATE CE Mark study's primary safety and efficacy
endpoints, the TRILUMINATE research team concluded that TriClip is
a safe and durable treatment option for high-risk patients with
symptomatic moderate or greater TR.
New Data for Patients with Severe Aortic Stenosis and Atrial
Fibrillation
Additional U.S. IDE data from Abbott's
structural heart portfolio were also presented during the PCR
e-Course, including findings on two of its devices* commercially
available in the EU: Amplatzer™ Amulet Left Atrial Appendage (LAA)
Occluder* – a stroke prevention product for people with atrial
fibrillation – and Portico™ transcatheter aortic valve replacement
(TAVR).
- Amplatzer Amulet has a consistent and high implant success
rate. First analysis of one-year clinical outcomes from the
roll-in cohort of the Amulet IDE trial demonstrated a high implant
success rate of 99.0% and a low rate of procedural complications at
3.5%.
- Portico with FlexNav™ demonstrates continued
safety and performance. Findings from the three studies of
Abbott's TAVR support Portico as a durable treatment option with
excellent hemodynamic results and long-term performance for
patients suffering from severe aortic stenosis who are at high risk
for open-heart surgery, while Abbott's new FlexNav™ delivery system
was shown to provide an enhanced safety profile for the Portico
device.
These positive findings on Amplatzer and Portico presented as
late-breaking clinical trials during the PCR e-Course add to the
mitral and tricuspid late-breaking data and demonstrate the breadth
of Abbott's structural heart portfolio.
"At Abbott, we are advancing science and innovative technology
to ensure people living with structural heart diseases have safe
and effective treatment options," said Michael Dale, senior vice president of Abbott's
structural heart business. "The data presented during this year's
PCR underscore our unwavering commitment to solve the health
challenges of those managing debilitating heart conditions."
For U.S. important safety information on MitraClip, visit:
https://www.structuralheartsolutions.com/us/mitraclip-isi.
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
107,000 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 and
@AbbottGlobal.
*These products are available commercially in the EU and are in
clinical trials in the United States.
The TriClip Transcatheter Tricuspid Valve Repair System is an
investigational device only in the U.S.
The Tendyne Transcatheter Mitral Valve Implantation System is an
investigational device only in the U.S.
The Amplatzer Amulet LAA Occluder is an investigational device
only in the U.S.
The Portico Transcatheter Aortic Valve Replacement System is an
investigational device only in the U.S.
The FlexNav Delivery system for Portico is an investigational
device only in the U.S.
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SOURCE Abbott