New Data on CoreValve(TM) and Evolut(TM) R Self-Expanding TAVI Systems Show Excellent Clinical Outcomes in Routine Clinical P...
May 16 2017 - 8:30AM
Late-Breaking
Real-World Study Results at EuroPCR from CoreValve ADVANCE and
Evolut R FORWARD Registries Show Strong Performance Consistent with
Data from CoreValve Randomized Clinical Trials
DUBLIN and PARIS - May 16,
2017 - Medtronic plc (NYSE:MDT) today
unveiled new positive data on the self-expanding CoreValve(TM)
platform from the CoreValve ADVANCE and Evolut R FORWARD clinical
studies - two large, rigorous global registries presented during
Hot Line/Late-Breaking Clinical Trial Sessions at the 2017 EuroPCR
Annual Meeting. Consistent with the excellent results achieved in
clinical trials, the studies reinforce the exceptional safety and
efficacy profile of the CoreValve(TM) System and the newer
CoreValve(TM) Evolut(TM) R System for the treatment of
transcatheter aortic valve implantation (TAVI) in "real-world"
patient populations with severe aortic stenosis.
CoreValve ADVANCE
Study
Five-year results from 465 patients in the ADVANCE Clinical Trial
demonstrated sustained, longer-term performance with the CoreValve
System in a "real-world" patient population. The CoreValve System
demonstrated sustained hemodynamic improvement in patients
available for long-term follow-up (9.7 mm Hg mean gradient at
discharge; 8.8 mm Hg mean gradient at five years). Additionally,
most patients continued to have symptomatic improvements with 81
percent of patients classified as NYHA (New York Heart Association)
class I or class II.
In a higher-risk patient population, survival is
in line with other five-year TAVI data in similar high-risk
patients.
"As TAVI continues to be evaluated in lower-risk
patients, the ability to demonstrate sustained valve durability
over time is of increasing importance," said Axel Linke, M.D.,
professor of medicine at the University of Leipzig, Heart Center,
Germany, and principal investigator of the ADVANCE Clinical Trial.
"At final, five-year follow-up, we are very pleased with the
excellent performance of the first-generation CoreValve device in
the ADVANCE study, which is one of the most rigorously designed
global TAVI trials to date."
Evolut R FORWARD
STUDY
Clinical results from the full patient cohort (n=1,038 patients)
enrolled in the Evolut R FORWARD Clinical Study demonstrated high
survival (98.1 percent) and a low rate of disabling stroke (1.8
percent) at 30-days post implant. The FORWARD study is a global,
single-arm, prospective study at 53 centers across four continents.
Patients enrolled in the study had a mean STS Predicted Risk of
Mortality estimate of 5.5 percent.
"The FORWARD results with a large patient cohort
are encouraging, as these data support the clinical safety and
effectiveness of the Evolut R System," said Prof. Eberhard Grube,
M.D., head, Center of Innovative Interventions (CIIC) at the
University Hospital Bonn, Germany, and co-principal investigator of
the FORWARD Study. "These initial 30-day outcomes help to further
demonstrate the advantages of the recapturable and repositionable
capabilities of the Evolut R System in routine clinical practice
and we look forward to conducting further follow-up that will
provide insights on contemporary TAVI clinical practice."
The Evolut R FORWARD study also showed excellent
hemodynamic performance in which the mean aortic valve gradient was
significantly reduced from 41.7 ± 16.1 mm Hg at baseline to 8.5 ±
5.6 mm Hg at discharge. Additionally, 98.1 percent of patients
experienced mild or none/trace aortic regurgitation, as well as a
low rate of major vascular complications (6.5 percent). New
pacemaker implantations remained low (17.5 percent) with no reports
of valve thrombosis reported at 30 days.
"With the recent expansion of TAVI into new
patient populations, it's critical that we collaborate with heart
teams to not only demonstrate clinical improvements in real-world
patient populations, but to show longer-term valve success," said
Rhonda Robb, vice president and general manager of the Heart Valve
Therapies business, a part of Medtronic's Cardiac and Vascular
Group. "Low rates of stroke, excellent hemodynamics and high
survival are consistent with the contemporary results we've seen
from our self-expanding TAVI platform, which continue to improve as
the technology advances."
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
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information contained therein.
Source: Medtronic plc via Globenewswire
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