Medtronic Study Finds CoreValve® System Benefits Aortic Stenosis Patients with Prior Coronary Bypass Surgery
January 28 2015 - 9:00AM
Analysis is First
to Show Significant Advantages for Transcatheter
Aortic Valve in
Patients with Prior CABG
DUBLIN and SAN DIEGO - January
28, 2015 - Medtronic plc (NYSE: MDT) revealed new one-year
clinical data showing that transcatheter aortic valve replacement
(TAVR) with the self-expanding CoreValve® System offers
advantages in survival and safety compared to surgical aortic valve
replacement (SAVR) in high risk aortic stenosis patients who have
previously undergone coronary artery bypass grafting (CABG)
surgery. This is the first analysis to evaluate a self-expanding
valve in prior-CABG patients within a trial of TAVR and SAVR.
Presented at the 2015 Annual Meeting of The
Society of Thoracic Surgeons (STS), the post-hoc sub-analysis of
the High Risk Study of the CoreValve U.S. Pivotal Trial included
226 prior-CABG patients who were either treated with TAVR
(N=115) or SAVR (N=111).
At one year, there was a significant difference
favoring TAVR with CoreValve in the combined primary study endpoint
of all-cause mortality or major stroke with an incidence of 11.4
percent in the TAVR group vs. 21.8 percent in the SAVR group
(p=0.04). Additionally, there was a
trend towards a survival advantage for patients who received TAVR
with CoreValve compared to SAVR (90.4 percent vs. 81.9 percent,
respectively; p=0.06) and lower rates of
cardiovascular mortality (7.0 percent vs. 13.8 percent,
respectively; p=0.10).
"Prior to now, the treatment of this patient
population has been confounded by the lack of data showing clinical
benefit of TAVR versus surgical aortic valve replacement for
prior-CABG aortic stenosis patients, who may have increased risks
of mortality and morbidity with re-operation.," said John Conte,
M.D., professor of surgery at The Johns Hopkins Hospital who
presented the data at STS. "The CoreValve System demonstrated
important clinical advantages including faster recovery compared to
surgical valve replacement offering heart teams an alternative to
open heart surgery for this patient population."
The analysis also showed reduced complications for
patients receiving TAVR vs. SAVR at one year, including lower rates
of acute kidney injury (5.3 percent vs. 16.3 percent; p=0.007), life threatening or disabling bleeding (14.0
percent vs. 43.5 percent; p<0.001), as well
as lower MACCE with the TAVR-treated patients (17.5 percent vs.
28.1 percent, respectively; p=0.05). There was
no difference in the overall rates of all stroke (10.6 percent vs.
14.3 percent, p=<0.40) or major stroke (8.8
percent vs. 6.6 percent; p=<0.54) between
the two patient groups
"Through our robust clinical trial program, we've
been able to address important unanswered questions about optimal
treatment with TAVR," said Rhonda Robb, vice president and general
manager of Heart Valve Therapies at Medtronic. "The favorable
outcomes from this analysis add to the growing body of clinical
evidence that reinforce the positive performance of the CoreValve
System, which to date is the only TAVR device to demonstrate
significant clinical advantages in this important subgroup of high
risk patients with prior-CABG procedures."
The CoreValve System is available for use in the
United States, following U.S. Food and Drug Administration (FDA)
approval in 2014 for patients at extreme risk and high risk for
surgery. Since receiving CE (Conformité Européenne) Mark in 2007,
the CoreValve System has been implanted in more than 70,000
patients in more than 60 countries. In addition, the
CoreValve System offers the broadest range of sizes available to
accommodate more 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, is the global leader in medical technology - alleviating
pain, restoring health and extending life for millions of people
around the world.
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
Jeff Warren
Investor Relations
+1-763-505-2696
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information contained therein.
Source: Medtronic plc via Globenewswire
HUG#1889959
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