Medtronic CoreValve® System Demonstrates Excellent Clinical Outcomes in First Report of 'Real-World' U.S. Experience
October 12 2015 - 3:00PM
First
Self-Expanding Valve Data from the STS/ACC TVT Registry Shows
Outcomes in Everyday Clinical Practice at 30 Days are Consistent
with the CoreValve U.S. Pivotal Trial
DUBLIN and SAN FRANCISCO -
October 12, 2015 - Medtronic plc (NYSE: MDT) today
released the first CoreValve® Transcatheter
Aortic Valve Replacement (TAVR) System outcomes data using
CoreValve data from The Society of Thoracic Surgeons and American
College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT)
Registry. The data show that everyday clinical experience from
6,160 CoreValve patients treated by a wide variety of heart team
implanters replicates the excellent outcomes achieved in robust
clinical trials. The primary outcomes of all-cause mortality and
stroke in the STS/ACC TVT Registry were numerically similar to the
findings in the rigorously designed CoreValve U.S. Pivotal Trial,
which demonstrated statistical superiority to surgical aortic valve
replacement in high risk patients.
The CoreValve patients in the STS/ACC TVT Registry
showed an exceptionally low rate of all-cause mortality (5.2
percent) and all stroke (2.6 percent) at 30 days, consistent with
pivotal trial results (6.9 percent all-cause mortality and 5
percent all stroke). The STS/ACC TVT Registry data represents all
patients entered into the registry who were implanted with the
CoreValve System since Food and Drug Administration (FDA) approval
in January 2014 through March 2015. The patients in the
STS/ACC TVT Registry were similar to those enrolled in the pivotal
trial with an average age 81.1 years (82.9 in the pivotal trial),
average STS risk model score of 8.7 (9.2 in the pivotal trial) and
similar comorbidity profiles including 83.7 percent of patients
being NYHA Class III/IV (89.4 percent in the pivotal trial).
"It is reassuring to see that the profound
clinical results in the U.S. CoreValve Pivotal studies were
replicated among patients at high or extreme surgical risk in a
'real-world' clinical setting," said Jeffrey J. Popma, M.D.,
director of Interventional Cardiology at the Beth Israel Deaconess
Medical Center, Boston, co-principal investigator of the U.S.
CoreValve Pivotal Trial and presenter of the STS/ACC TVT Registry
CoreValve data at the Transcatheter Cardiovascular
Therapeutics TCT scientific meeting. "The favorable results
from the CoreValve analyses are likely attributable to operator
experience, thoughtful patient selection, and effective education
and training based on the 'Best Practices' learned in the U.S.
Pivotal Studies, including the use of CT-based sizing. We believe
that these results indicate that the CoreValve self-expanding
bioprosthesis is safe and effective in patients with severe aortic
stenosis unsuitable for surgery across a wide spectrum of U.S.
medical centers."
Compared to the CoreValve U.S. Pivotal Trial, the
STS/ACC TVT Registry CoreValve data analyses also demonstrated:
- CoreValve implantation was successful in 98.0
percent of cases (96.8 percent in the pivotal trial) with just 0.7
percent of cases requiring conversion to surgery (0.2 percent in
the pivotal trial)
- With the CoreValve System's low delivery profile,
89.3 percent of patients were able to be treated via transfemoral
access (77.3 percent in the pivotal trial) with an extremely low
rate of major vascular complications (1.1 percent compared to 7.5
percent in the pivotal trial)
- Only 1.5 percent of patients required valve
related readmission (5.9 percent in the pivotal trial)
CoreValve hemodynamic performance was excellent
with a single-digit mean gradient (a measure of blood flow through
the valve) of 7.7 ± 4.2 mm Hg at 30 days and 8.1 ± 3.9 mm at one
year. As in the clinical trial setting, patients experienced
dramatic improvements in quality of life (Kansas City
Cardiomyopathy Questionnaire reduction from 40.9 to 68.7, the
strongest improvements possible via the test), as well as
significant reductions in symptoms (from 83.8 percent NYHA Class
III/IV to 13.4 percent) at 30 days. Excellent results continued in
380 patients followed out to one year with all-cause mortality at
18.8 percent, while stroke remained low at 2.6 percent. There were
no reports of valve thrombosis through one year.
The CoreValve System is approved by the U.S. Food
and Drug Administration (FDA) for patients at extreme risk and high
risk for surgery. Since receiving CE (Conformité Européenne)
Mark in 2007, the CoreValve System, and the recently approved
CoreValve Evolut R system have been implanted in more than 80,000
patients in more than 60 countries.
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 85,000 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
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX 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
HUG#1958365
Medtronic (NYSE:MDT)
Historical Stock Chart
From Apr 2024 to May 2024
Medtronic (NYSE:MDT)
Historical Stock Chart
From May 2023 to May 2024