Medtronic Evolut(TM) PRO TAVR System with Advanced Sealing Maintains Excellent Outcomes Over Time
(Thomson Reuters ONE) -
Evolut PRO Valve Well-Positioned for Future with New Study Unveiled to
Investigate Expanded Patient Population
DUBLIN and DENVER - November 2, 2017 - Medtronic plc (NYSE:MDT) today presented
new data at the Transcatheter Cardiovascular Therapeutics (TCT) Annual Meeting
showcasing the excellent clinical performance of the Evolut(TM) Transcatheter
Aortic Valve Replacement (TAVR) platform. Six-month data from the newest-
generation Evolut PRO System demonstrated continued benefits of its unique valve
design. Results from the STS/ACC TVT Registry with the Evolut R in patients
with bicuspid aortic valve disease were also presented.
Evolut PRO 6-Month Outcomes
Following the exceptional early clinical outcomes at 30-days from the Evolut PRO
U.S. Study, follow-up data in 60 patients continued to demonstrate low rates of
paravalvular leak (PVL) as 88 percent of patients showed no or trace PVL at six
months. Additionally, rates of all-cause mortality and disabling stroke were low
at six months with no instances of coronary obstruction or valve thrombosis, and
the permanent pacemaker implantation rate remained low at 11.7 percent.
"These latest six-month results suggest that the Evolut PRO valve, with its
self-expanding nitinol frame and outer pericardial tissue wrap, maintains a very
low incidence of paravalvular leak," said John Forrest, M.D., director of
interventional cardiology at Yale New Haven Hospital in New Haven, Conn. "It is
encouraging to observe the sustained low rates of PVL over time combined with
exceptional hemodynamics, while maintaining a low rate of new pacemaker
implants."
STS/ACC TVT Registry Bicuspid Data
Further strengthening the clinical evidence for the Evolut TAVR platform,
separate clinical evidence was unveiled at TCT from the STS/ACC TVT Registry,
which compared patients at high surgical risk with bicuspid aortic valve disease
(N=191) to those with severe tricuspid aortic valve disease (N=6526) in real-
world clinical practice. Patients with bicuspid aortic valve disease are unique
in that they have two aortic valve leaflets instead of the more common three
leaflets (tricuspid).
At 30-days, clinical outcomes were similar for the bicuspid group compared to
the tricuspid group with lower rates of all-cause mortality (2.2 percent vs.
3.2 percent), stroke (2.6 percent vs. 3.4 percent) and major vascular
complications (0.5 percent vs. 1.6 percent). Additionally, hemodynamic outcomes
were similar between the groups with both patient populations showing a
symptomatic improvement over time.
"The results from this large, real-world analysis are promising indicators for
new patient populations in the future," said Jeffrey J. Popma, M.D., director of
Interventional Cardiology at the Beth Israel Deaconess Medical Center, Boston,
Mass. "We look forward to further study and evaluation."
To further support TAVR clinical evidence for the treatment of bicuspid
patients, Medtronic announced plans to conduct a new study in a bicuspid patient
population. The study will utilize the Evolut PRO TAVR system.
The CoreValve Evolut TAVR platform consists of the CoreValve, CoreValve Evolut R
and the CoreValve Evolut PRO systems, all of which have received CE mark and FDA
approval for use in severe aortic stenosis patients at an intermediate surgical
risk or greater.
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 84,000 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
+1-763-381-1204
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
Unternehmensinformation / Kurzprofil:
Datum: 02.11.2017 - 15:00 Uhr
Sprache: Deutsch
News-ID 566439
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