Clinical Trials Show Strong Long-Term Performance with the Medtronic CoreValve TAVR System
March 10 2018 - 12:15PM
Presented at
ACC.18, Five-Year Follow-up from the CoreValve Extreme Risk and
NOTION Studies Show Sustained Valve Function and Durability Over
Time
DUBLIN and ORLANDO - March 10,
2018 - Medtronic plc (NYSE: MDT) today unveiled outcomes from
the CoreValve U.S. Pivotal Extreme Risk Study and the real-world
NOTION trial (Nordic Aortic Valve Intervention Trial), both of
which examined patients with the CoreValve(TM) transcatheter aortic
valve replacement (TAVR) system at five years post-implant.
Presented at the American College of Cardiology (ACC) 67th Annual
Scientific Session, results from the studies demonstrated that
patients implanted with the CoreValve TAVR system showed strong
hemodynamic performance (blood flow) and improved quality of life
out to five years.
The physician-initiated NOTION trial studied an
all-comers population of 280 patients at least 70 years old who
were randomized to surgical (SAVR) or transcatheter aortic valve
replacement using the CoreValve System. Results at five-year
follow-up showed similar rates of all-cause mortality (27.7 percent
for TAVR versus 27.7 percent for SAVR) and superior hemodynamic
performance for TAVR (mean aortic valve gradient of 8.22 mm Hg)
compared to surgery (13.71 mm Hg).
"These five-year outcomes of the NOTION data add
to the mounting body of longer-term evidence supporting the
effectiveness of TAVR, said H. Gustav Thyregod, M.D., Ph.D.,
cardiac surgeon in the department of cardiac surgery at The Heart
Center, Rigshospitalet, in Copenhagen, Denmark, and presenter of
the NOTION data at the meeting. "We're pleased to see the strong
hemodynamic performance maintained over time without any indication
of valve deterioration."
Also presented at the meeting were the final
five-year results from the CoreValve U.S. Pivotal Extreme Risk
Study, which enrolled the first US IDE cohort of patients ever to
be treated with the self-expanding CoreValve TAVR system. Results
from the study continued to show positive outcomes at five years
for the surviving patients - all of whom were deemed to be facing
considerable harm or mortality with a surgical valve replacement.
Patients implanted with the CoreValve system maintained a notable
improvement in quality of life (mean change from baseline in KCCQ
of > 20 points at 5 years) and sustained low mean gradients
(7.63 mm Hg).
"It is remarkable to see patients, whose only
aortic valve replacement option was to undergo a TAVR procedure,
continue to live an improved quality of life five years later,"
said Pieter Kappetein, M.D., vice president and chief medical
officer of the Heart Valve Therapies business, which is part of the
Cardiac and Vascular Group at Medtronic. "While the TAVR therapy
continues to show promise in less sick patients, it's important to
acknowledge that the early pioneers of this therapy were those who
truly had very limited treatment options. It's satisfying to see
that many of these early patients continue to do well with the
self-expanding TAVR platform, especially as the therapy expands to
lower-risk patients who are expected to live longer."
Following the launch of the self-expanding
CoreValve System in the U. S. in 2014, the CoreValve Evolut R
System became the first-and-only recapturable and repositionable
TAVR device approved in the U.S. for severe aortic stenosis
patients at a high or extreme risk for surgery in 2015. The Evolut
R system received CE (Conformité Européene)
Mark for high- and extreme-risk severe aortic stenosis patients in
2015, and for intermediate-risk patients in 2016. In 2017, the
third-generation Evolut PRO TAVR system was approved in the U.S.
and Europe for extreme-, high- and intermediate-risk patients.
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 84,000 people worldwide, serving physicians,
hospitals and patients in more than 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
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Source: Medtronic plc via Globenewswire
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