ABBOTT PARK, Ill., May 17, 2021
/PRNewswire/ -- Abbott (NYSE: ABT) today announced it has
received CE Mark for its latest-generation transcatheter aortic
valve implantation (TAVI) system, Navitor™, making the minimally
invasive device available for people in Europe with severe aortic stenosis who are at
high or extreme surgical risk. With the Navitor valve, the company
is advancing TAVI (also referred to as TAVR, or transcatheter
aortic valve replacement) therapies with innovations including a
unique design to prevent blood leaking around the valve. Using
Abbott's industry-leading FlexNav™ delivery system, the Navitor
TAVI system is the latest addition to the company's comprehensive
structural heart transcatheter portfolio that offers physicians and
patients less invasive options to treat heart diseases.
Aortic stenosis restricts blood flow through the aortic heart
valve to the rest of the body, which can lead to heart failure and,
in certain cases, sudden cardiac death.1 For some people
diagnosed with severe aortic stenosis, open-heart surgery is
considered a high-risk procedure due to the potential complications
stemming from age, frailty or having multiple other diseases or
conditions.2 TAVI serves as a less invasive alternative
to surgical aortic valve replacement and can reduce symptoms and
improve the lives of patients with this debilitating condition.
"With an aging world population and with aortic stenosis cases
projected to double in Europe and
the U.S. in the next few decades, the need for innovative,
minimally invasive solutions is critical," said Lars Søndergaard,
M.D., professor of Cardiology, Rigshospitalet, Copenhagen University Hospital in Denmark, who served as co-principal
investigator for the global Navitor TAVI system clinical study.
"While transcatheter valve replacement has for some time been a
standard of care for patients with a narrowing of
the aortic valve, Navitor helps to address challenges we
sometimes find in current TAVI systems when we encounter complex
patient anatomies that can lead to potential
complications."
Navitor features a unique fabric cuff (NaviSeal™) that works
with the cardiac cycle to reduce or eliminate a backflow of blood
around the valve frame known as paravalvular leak (PVL), a common
complication following TAVI procedures. The new device is the only
self-expanding TAVI system with intra-annular (within the native
valve) leaflets and large frame cells – features designed to help
improve access to critical coronary arteries to facilitate future
interventions to treat coronary artery disease (CAD). The new
design additionally provides improved hemodynamics, or better blood
flow.
The Navitor device is implanted with Abbott's
FlexNav delivery system, which received CE Mark in 2020 and
offers a slim design with the lowest TAVI delivery system profile,
allowing treatment of people with vessels as small as 5.0 mm. The
slim catheter can accommodate different aortic anatomies for
stable, predictable and accurate valve delivery and placement.
"The innovative design of the Navitor valve paired with the
FlexNav delivery system streamlines and simplifies TAVI procedures
for physicians, enabling better valve placement and performance for
patients so they can get back to living fuller, healthier lives,"
said Michael Dale, senior vice president of Abbott's
structural heart business. "This approval strengthens our
structural heart portfolio of minimally invasive offerings by
providing new options and improvements to treat a life-threatening
heart condition."
For more information on Navitor, please
visit: http://www.navitorvalve.com.
The Navitor Transcatheter Aortic Valve and FlexNav Delivery
System are approved for investigational use 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
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 Mayo Clinic. Transcatheter aortic valve replacement
(TAVR). August 2020.
2 Bach DS, Siao D, Girard SE, Duvernoy C, McCallister BD
Jr, Gualano SK. Evaluation of patients with severe symptomatic
aortic stenosis who do not undergo aortic valve replacement: the
potential role of subjectively overestimated operative risk. Circ
Cardiovasc Qual Outcomes. 2009. November; 2 6: 533– 9.
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SOURCE Abbott