ABBOTT PARK, Ill., Sept. 20, 2021
/PRNewswire/ -- Abbott (NYSE: ABT) today announced that the U.S.
Food and Drug Administration (FDA) has approved the company's
Portico™ with FlexNav™ transcatheter aortic valve replacement
(TAVR) system to treat people with symptomatic, severe aortic
stenosis who are at high or extreme risk for open-heart surgery.
With this latest TAVR (also referred to as TAVI, or transcatheter
aortic valve implantation) advancement, Abbott continues to offer
the industry's leading portfolio of structural heart solutions that
include innovative, minimally invasive therapies to repair or
replace diseased or damaged heart valves or close openings in the
heart.
Aortic stenosis is one of the most common and life-threatening
heart valve diseases. It occurs when the aortic valve's opening
narrows and restricts blood flow from the left ventricle to the
aorta.1 Patients with the disease can experience
breathlessness, chest pressure or tightness, fainting,
palpitations, fatigue, and heart murmurs. The condition can
ultimately lead to heart failure.2 While many people
don't have noticeable symptoms, more than one in eight aged 75 and
older has moderate or severe aortic stenosis, which reduces the
heart's pumping ability.3 Prior to TAVR, the standard of
care for severe aortic stenosis was surgical aortic valve
replacement, but not all patients were candidates for open-heart
surgery.
"For people in the U.S. suffering from aortic stenosis and
unable to have surgery, the Portico with FlexNav system offers a
safe and effective treatment option," said Raj Makkar, M.D.,
associate director of Interventional Technologies at Cedars-Sinai's
Smidt Heart Institute, who served as co-principal investigator for
the study that led to FDA approval. Gregory
Fontana, M.D., national director, Cardiothoracic Surgery at
Hospital Corporation of America and American Research Institute,
also served as co-principal investigator of the Portico IDE
study.
With years of experience globally, Portico is a self-expanding
TAVR valve with intra-annular (within the native valve) leaflets
that help provide optimal blood flow (hemodynamics) when placed
inside a patient's natural valve. The structure of the replacement
valve also preserves access to the critical coronary arteries for
future coronary interventions. The Portico device is implanted
using Abbott's FlexNav delivery system, which features a slim
design to accommodate different patient anatomies and small
vessels, and optimizes flexibility, ease of tracking and precision
of valve placement.
"With the approval of our TAVR therapy in the U.S., physicians
now have access to an even more robust set of solutions to treat
structural heart disease," said Michael
Dale, senior vice president of Abbott's structural heart
business. "This latest and important introduction of Portico with
FlexNav represents another milestone in our work to advance our
mission to restore health and improve quality of life so more
people can get back to living fuller lives."
For more information on Portico, please visit
https://abbo.tt/Portico.
For U.S. important safety information on Portico, visit
https://abbo.tt/PorticoISI.
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
109,000 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.
1 American Heart Association. Aortic Stenosis
Overview. 2020.
2 Osnabrugge RLJ, Mylotte D, Head SJ, et al; Aortic
Stenosis in the Elderly: Disease Prevalence and Number of
Candidates for Transcatheter Aortic Valve Replacement: A
Meta-Analysis and Modeling Study. Journal of the American College
of Cardiology. 2013; 11:1002-1012.
3 Nkomo VT, Gardin JM, Skelton TN, et al. Burden of
valvular heart diseases: a population-based study. Lancet
2006;368:1005-11
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SOURCE Abbott