Medtronic Announces CE Mark and European Launch of Recaptureable TAVI System Now Available for Severe Aortic Stenosis Patient...
January 17 2017 - 09:30AM
Larger Device
Offers Treatment to Patients Without a
Previous TAVI Option
DUBLIN - Jan. 17, 2017
- Medtronic plc (NYSE:MDT) today announced the
CE (Conformité Européenne) mark and European launch of the
CoreValve(TM) Evolut(TM) R 34 mm valve-the largest sized
transcatheter aortic valve implantation (TAVI) system available in
Europe. The new Evolut R 34 mm valve is approved for severe aortic
stenosis patients who are at intermediate, high or extreme risk for
surgery with an annulus size ranging from 26-30 mm. This large
valve segment is estimated to account for approximately 20-25
percent of the eligible European TAVI patient population.
Previously, some of these patients were unable to receive a TAVI
due to the larger size of their native diseased aortic valve.
"It's important that patients with large aortic
root anatomies can also have access to this recapturable TAVI
system, which has proven to be an excellent treatment option for
many patients," said Darren Mylotte, M.D., interventional
cardiologist at the University Hospitals and National University of
Ireland in Galway, Ireland. "Consistent with the Evolut R platform,
the 34 mm valve delivery system assists with accurate placement
with the option to recapture and reposition if needed; this gives
physicians great confidence that exceptional outcomes can be
achieved for our patients."
The Evolut R 34mm valve is delivered through the
EnVeo(TM) R Delivery Catheter System, which features an InLine
Sheath. The system delivers the lowest, true delivery profile
currently on the market (16 Fr equivalent, approximately 1/5 inch
or 1/2 cm), which provides a greater opportunity to treat patients
with smaller vessels through the preferred transfemoral access
route. The Evolut R System, with its self-expanding nitinol frame,
is designed to fit within the native aortic valve, using its
supra-annular valve position to help achieve excellent hemodynamic
performance.
"We look forward to working with physicians across
Europe to offer this highly anticipated valve size to the thousands
of patients who were previously unable to receive TAVI due to valve
size," said Rhonda Robb, vice president and general manager of the
Heart Valve Therapies business, a part of Medtronic's Cardiac and
Vascular Group. "With this approval, the Evolut R platform now
treats the broadest annulus range of any TAVI system on the market
and expands the patient population that can now receive this
life-saving therapy."
The CoreValve Evolut R 34 mm valve received Food
and Drug Administration (FDA) approval in the United States in
October 2016 for severe aortic stenosis patients who are at high or
extreme risk for surgery with an annulus size ranging from 26-30
mm.
In collaboration with leading clinicians,
researchers and scientists worldwide, Medtronic offers the broadest
range of innovative medical technology for the interventional and
surgical treatment of cardiovascular disease and cardiac
arrhythmias. The company strives to offer products and services
that deliver clinical and economic value to healthcare consumers
and providers around the world.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, is among the world's largest medical technology, services
and solutions companies - alleviating pain, restoring health and
extending life for millions of people around the world. Medtronic
employs more than 88,000 people worldwide, serving physicians,
hospitals and patients in approximately 160 countries. The company
is focused on collaborating with stakeholders around the world to
take healthcare Further, Together.
Any forward-looking statements
are subject to risks and uncertainties such as those described in
Medtronic's periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from
anticipated results
-end-
Contacts:
Joey Lomicky
Public Relations
+1-763-526-2494
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Medtronic plc via Globenewswire
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