Medtronic CoreValve® Evolut(TM) R System Yields Exceptional Outcomes in First Clinical Study
March 14 2015 - 3:00PM
No Mortality or
Stroke at 30-days and Excellent Procedural Results with
Next-Generation Recapturable Valve
DUBLIN and SAN DIEGO -
March 14, 2015 - Medtronic plc (NYSE: MDT)
today announced initial clinical outcomes for its next-generation
CoreValve®
Evolut(TM) R System.
At 30-days, the new recapturable, self-expanding valve showed no
incidents of all-cause mortality or stroke in a high and extreme
risk patient population. Data from the Evolut R Study, which
enrolled 60 patients from six centers in the United Kingdom,
Australia and New Zealand, were unveiled today at the 64th Annual
Scientific Session of the American College of Cardiology (ACC.15).
The CoreValve Evolut R System is not approved for commercial use in
the United States where it is currently undergoing clinical
trials.
"Initial clinical experience with the Evolut R
system is remarkable and ushers in a new era of TAVR technology
that provides increased confidence with recapturability, excellent
procedural results, and impressive clinical outcomes," said Ian
Meredith, M.D., of Monash Heart - Monash Health, Melbourne,
Australia, who is one of the investigators of the study. "The
14 French equivalent delivery system allowed transfemoral access
for most patients and the recapturable technology enabled
implanters to optimize valve placement for improved annular sealing
and reduced conduction disturbances without compromise on mortality
or stroke."
The new EnVeo(TM) R Delivery Catheter System
provides a new InLine(TM) Sheath that significantly reduces the
profile to the lowest on the market (14 Fr equivalent, less than
1/5 inch). Transfemoral access was possible in all but one patient
(98.3 percent) in a population that included patients with
vasculature as small as 5.0mm diameter. Physicians took advantage
of the new capabilities of the CoreValve Evolut R System with all
recapture attempts performed safely with zero strokes (0.0
percent). Additionally, correct valve position with one device was
achieved in 98.3 percent of patients, and there were no cases of
valve dysfunction, procedural death, annular rupture, coronary
occlusion, valve embolization, or conversion to surgery in the
study. The pacemaker rate was low at 11.7 percent.
The supra-annular valve design of the CoreValve
Evolut R System resulted in low, single-digit mean aortic gradients
(a commonly used threshold of exceptional blood flow) at each
follow-up visit (9.2mm Hg in early follow-up at 24hrs to 7 days
post procedure, and 8.1mmHg at 30-days). The recapturable Evolut R
valve features a new extended sealing skirt on the 26 and 29 mm
sizes that further promotes valve sealing at the annulus resulting
in low rates of paravalvular leak (PVL) with 96.6 percent of
patients having < = mild PVL at 30-days with no patients
having severe PVL (0.0 percent).
The CoreValve Evolut R System builds off of the
successful CoreValve platform, which has been implanted in more
than 75,000 patients in more than 60 countries. The 23 mm, 26 mm
and 29 mm sizes of the CoreValve Evolut R transcatheter valve and
the CoreValve EnVeo R Delivery Catheter System are available in
Europe and other countries that recognize the CE mark.
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 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:
Wendy Dougherty
Public Relations
+1-763-381-1204
Jeff Warren
Investor Relations
+1-763-505-2696
This
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information contained therein.
Source: Medtronic plc via Globenewswire
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