- Abbott's new Navitor device features advancements to improve
patient care, including reducing or eliminating risk of blood
leakage around valve implant
- Transcatheter aortic valve implantation (TAVI) offers minimally
invasive alternative to surgery for people with aortic stenosis, a
common and life-threatening heart valve disease
ABBOTT
PARK, Ill., Jan. 17,
2023 /PRNewswire/ -- Abbott (NYSE: ABT) today
announced that the U.S. Food and Drug Administration (FDA) has
approved the company's latest-generation transcatheter aortic valve
implantation (TAVI) system, Navitor™, to treat people with severe
aortic stenosis who are at high or extreme risk for open-heart
surgery. The Navitor TAVI system is the latest addition to the
company's comprehensive transcatheter structural heart portfolio
that offers less invasive treatment options to physicians and
patients for some of the most common and serious heart
diseases.
Aortic stenosis occurs when the aortic valve's opening narrows,
restricting blood flow to the body. Left untreated, it can lead to
heart failure and death. For patients with severe aortic stenosis
who are at high or extreme surgical risk due to the potential
complications stemming from age, frailty, or having multiple other
diseases or conditions, physicians may opt for a minimally invasive
procedure using TAVI therapies such as the Navitor system.
"Abbott's Navitor device features advancements to help doctors
safely and effectively treat patients with aortic stenosis,
including a design that reduces the backflow of blood around the
valve that's often a complication following TAVI procedures," 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. "The innovative Navitor system also offers physicians
stable and accurate device placement, even in challenging patient
anatomies."
Navitor features a unique fabric cuff (NaviSeal™) to reduce or
eliminate the backflow of blood around the valve frame known as
paravalvular leak (PVL). Additionally, the new device is the only
self-expanding TAVI system with leaflets within the native valve;
this design can help improve access to coronary arteries to
facilitate future procedures for treating coronary artery disease.
The system provides excellent hemodynamics, or blood flow,
through the valve. The Navitor device is implanted using Abbott's
FlexNav™ delivery system, which features a slim design to
accommodate different patient anatomies and small vessels
for stable, predictable and accurate valve delivery and
placement.
"Our Navitor valve builds upon our industry-leading portfolio of
minimally invasive devices that surpass existing standards of care
to address a range of heart diseases," said Michael Dale,
senior vice president of Abbott's structural heart business.
"Navitor is the first TAVI system to offer optimal hemodynamics in
all valve sizes while also preserving options for lifetime disease
management, an important consideration for physicians and patients
when selecting a TAVI solution. Receiving this approval is a major
next step in our mission to help people live better lives through
better health."
For U.S. important safety information on Navitor, visit
https://abbo.tt/NavitorISI.
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.
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.
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SOURCE Abbott