ABBOTT PARK, Ill., March 5, 2020
/PRNewswire/ -- Abbott (NYSE: ABT) today announced it has
received CE Mark for the new FlexNav™ delivery system for the
company's Portico™ transcatheter aortic valve implantation (TAVI)
system, enabling marketing authorization in Europe. With the approval, physicians
implanting Portico can benefit from improved delivery, flexibility
and navigation during implant, even in complex cardiac
anatomies.
The new FlexNav delivery system demonstrates Abbott's commitment
to developing new tools for doctors to treat patients requiring a
transcatheter aortic valve implant. The approval and launch of the
FlexNav delivery system follow first global implants in a clinical
study of Abbott's next generation Navitor™ TAVI system, which were
recently conducted at Rigshospitalet in Copenhagen, Denmark, by a clinical team led by
Prof. Lars Sǿndegaard, M.D., professor of Cardiology,
Rigshospitalet, Copenhagen University
Hospital in Denmark. Prof. Lars
Sǿndegaard, M.D., also serves as co-principal investigator for the
trial.
Transcatheter aortic valve replacement (TAVR) is a minimally
invasive alternative to surgical aortic valve replacement for
patients at high or extreme risk for open heart surgery who are
diagnosed with severe aortic stenosis, a condition which restricts
blood flow through the valve. While valve technology improvements
have helped reduce adverse events and improve patient outcomes,
improvements to delivery systems are critical to improving the
placement and positioning of the valve. Based on physician
feedback, Abbott developed the FlexNav delivery system to
incorporate more stability, predictability and placement accuracy
into the TAVI procedure.
"As a therapy, TAVR is now fairly mainstream and has helped
countless patients around the world live better lives, but
physicians have continued to seek improvements to how we deliver a
valve to optimize outcomes for our patients," said Francesco Bedogni, M.D., interventional
cardiologist and head of Cardiology at the IRCCS Policlinico San
Donato in Italy, who served as
principal investigator for the FlexNav sub-study within the Portico
Global Investigational Device Exemption (IDE) Trial. "With Abbott's
new FlexNav delivery system, the company has introduced a delivery
system that improves the implant process even in incredibly complex
cardiac anatomies."
Clinical experience with the FlexNav delivery system has yielded
positive outcomes for patients to date. Data presented at the 31st
annual Transcatheter Cardiovascular Therapeutics (TCT) scientific
symposium in September 2019 showed
that within the Portico U.S. IDE Study, patients who received a
Portico valve implanted with the FlexNav Delivery System saw no
deaths, no strokes and low rates of major vascular complications
and new permanent pacemaker implants after 30 days.
"Within the field of TAVI, delivery systems often don't receive
the attention of the evolving technology of the valves themselves,
but improvements to a delivery system can result in substantial
benefits to patients," said Neil
Moat, M.D., chief medical officer of Abbott's structural
heart business and a physician who has performed several hundred
TAVI procedures. "If we look at the total TAVI procedure,
innovation around both the valve itself and also how it's delivered
during an implant are both central to improving outcomes."
The Portico Transcatheter Aortic Valve and FlexNav Delivery
System are approved for investigational use only in the
U.S.
The Navitor Transcatheter Aortic Valve is Abbott's next
generation TAVI valve, currently under investigation in
the United States. The Navitor
valve is approved only for investigational use.
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.
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SOURCE Abbott