- The investigational transcatheter aortic valve implantation
(TAVI) system will complement Abbott's Navitor™ TAVI system for
aortic stenosis, a common and life-threatening heart valve
disease
- The investigational system is designed to offer best-in-class
heart blood flow, ease of use and precision
- Approximately 9% of older Americans have aortic
stenosis1
ABBOTT
PARK, Ill., Nov. 25,
2024 /PRNewswire/ -- Abbott (NYSE: ABT) today
announced the first patient procedures with its investigational
transcatheter aortic valve implantation (TAVI) balloon-expandable
system for treating symptomatic severe aortic stenosis. This
investigational Abbott TAVI system is the first step toward
Abbott's software-guided balloon-expandable TAVI system and is
designed to build a foundation for artificial intelligence (AI)
guided procedures. Once the investigational balloon-expandable
system completes clinical development and is approved by regulatory
authorities, Abbott's structural heart portfolio will offer
physicians another TAVI management option to meet the
patient's needs along with the company's Navitor™ TAVI system,
which is already commercially available.
The aortic valve is a heart valve that controls the flow of
oxygen-rich blood to the body. With age, calcium may build up in
the valve and cause it to narrow – a condition known as aortic
stenosis – resulting in the heart needing to work harder to pump
blood through the valve. Left untreated, aortic stenosis can cause
symptoms, such as chest pain, shortness of breath and fainting, and
it can weaken the heart and become life-threatening. Patients who
are at risk of open-heart surgery due to age, frailty or having
multiple other conditions may benefit from minimally invasive
treatment options where a device is delivered to the heart through
an artery in the leg. Aortic stenosis remains the most common
primary valve disease and its prevalence increases with age,
ranging from approximately 2% in adults 70-80 years of age to 9% in
adults older than 80 years.1
The investigational system is a type of balloon-expandable TAVI
device, which works by crimping the new heart valve on a deflated
balloon. The balloon with the mounted valve is then inserted into
the body through an artery in the groin and routed up to the heart.
Once properly positioned inside the narrowed heart valve, the
balloon is inflated to expand the new valve, taking over the
function of the patient's narrow native heart valve. The balloon is
then deflated and removed from the body.
"Transcatheter aortic valve implantation treatment has
benefitted both physicians and patients over the years, but
physicians have come to understand one device does not fit all
their patients with aortic stenosis," said Azeem Latib, M.D., section head and director of
interventional cardiology and director of structural heart
interventions at Montefiore Health System, who conducted the first
procedures with the device alongside cardiac surgeon,
Vinayak Bapat, M.D., chair of
cardiothoracic surgery at the Minneapolis Heart Institute. "We, and
hospitals worldwide, remain focused on helping this growing patient
population by investigating and providing expanded treatment
options that adapt to the unique needs and anatomies of
patients."
Continued research and expansion of TAVI solutions is necessary
for the industry as the needs of physicians and patients evolve.
Leveraging insights from physicians, the latest technology
advancements and key learnings from the company's TAVI product
portfolio, Abbott has developed this differentiated TAVI platform
with the objective of building a foundation for the incorporation
of AI-guided procedural capabilities. The goal is to enhance ease
of use and precision, while offering best-in-class hemodynamic
performance, or blood flow through the valve.
"Abbott's experience in the TAVI market gives us a unique
understanding of the remaining unmet needs, and we're applying this
knowledge to develop future therapies to close that gap," said
Sandra Lesenfants, senior vice president of Abbott's structural
heart business. "By closely partnering with physicians on research
into new innovations, we're positioned to advance investigational
therapies that have the potential to transform patient
treatment."
The first-in-human procedures were successfully conducted at the
Republican Centre of Emergency Medicine in Tashkent, Uzbekistan, in collaboration with
site principal investigator, interventional cardiologist, Saidamir
Djafarov, M.D.
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 114,000
colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com and
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1 Iung B, Vahanian A. Epidemiology of valvular heart
disease in the adult. Nat Rev Cardiol. 2011;8:162-72.
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SOURCE Abbott