Medtronic Avalus(TM) Surgical Aortic Valve Shows Positive Outcomes in One-Year Clinical Trial Results
October 03 2016 - 11:00AM
Presented at
EACTS, First Data of New Pericardial
Heart Valve Finds High Survival and
Excellent Hemodynamics
DUBLIN and BARCELONA - Oct. 3,
2016 - Medtronic plc (NYSE: MDT) today announced positive
clinical data for its investigational Avalus(TM)
pericardial aortic surgical valve, intended for the treatment of
aortic valve disease. Presented at the 30th European Association
for Cardio-Thoracic Surgery (EACTS) Annual Meeting for the first
time, results from the PERIGON (PERIcardial SurGical AOrtic Valve
ReplacemeNt) Pivotal Trial showed low rates of adverse
valve-related events, high survival and improved hemodynamic
performance at one year.
One of the largest, most comprehensive and modern
data sets of surgical aortic valve replacement (SAVR) patients, the
PERIGON Pivotal Trial is a single arm, non-randomized, prospective
study of approximately 1,300 patients from 40 clinical sites across
Europe, Canada, Japan and the United States. In the cohort
presented at EACTS, outcomes of 270 patients were analyzed at the
one-year endpoint. The vast majority (91 percent) of patients were
at low mortality risk for open heart surgery (STS<=4 percent),
with the remaining 8 percent at intermediate risk (STS=4 to 8
percent) and <1 percent at high risk (STS>=8 percent). At one
year, all patients showed low rates of all-cause mortality (3.6
percent) and cardiac death (1.1 percent).
"As surgical aortic valve replacement remains one
of the most important treatment options for patients, the one-year
outcomes from the PERIGON trial demonstrate how the advanced design
elements of Avalus contribute to positive valve performance and
clinical outcomes," saidRobert Klautz, M.D., cardiothoracic
surgeon, head of the department of cardiothoracic surgery at the
Leiden University Medical Center in The Netherlands, and co-primary
investigator of the PERIGON trial and presenter of the one-year
results at EACTS. "The value of this large, contemporary dataset is
that it allows surgeons to better understand treatment for today's
SAVR patients, as opposed to data from older studies that may not
be as representative."
The primary analysis demonstrated positive
clinical outcomes at one year, with low linearized rates of
thromboembolism (2.2 percent), endocarditis (1.0 percent), all
paravalvular leaks (0.5 percent), all hemorrhages (3.7 percent) and
major hemorrhages (2.7 percent). No thrombosis, hemolysis, severe
paravalvular leaks or structural valve deterioration were observed
at one year.
Additionally, patients treated with the
supra-annular design of the Avalus valve also experienced improved
hemodynamic (blood flow) performance with mean aortic gradients
improving from 42.3 mmHg at baseline to 12.6 mmHg at one year.
Additionally, nearly three-fourths of patients improved one or two
NYHA Functional Classes from baseline to one year across all valve
sizes.
"With more than 25 years of experience in the
surgical valve space, we have designed the Avalus valve through
close collaboration with expert surgeons. The valve design concepts
and contemporary features are designed to help facilitate
procedural ease of use while enabling the lifetime management of
the patient," said Rhonda Robb, vice president and general manager
of the heart valve therapies business, a part of Medtronic's
Cardiac and Vascular Group. "We are very pleased to see the initial
positive outcomes from this trial and intend to report on the
growing body of evidence at future congresses."
The Avalus valve is not approved for commercial
use in the United States or Europe.
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 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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information contained therein.
Source: Medtronic plc via Globenewswire
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