Medtronic Also Begins Feasibility Study of Evolut TAVR
System in Moderate and Asymptomatic Aortic Stenosis
Patients
DUBLIN, Oct. 14, 2020 /CNW/ -- Medtronic plc (NYSE:MDT),
a global leader in structural heart therapies, today announced it
will begin a randomized, head-to-head study comparing two
transcatheter aortic valve replacement (TAVR) systems in patients
with severe symptomatic aortic stenosis (ssAS). The SMall Annuli
Randomized To Evolut™ or Sapien (SMART) post-market trial will
compare valve safety and performance of the self-expanding
Medtronic Evolut™ PRO and PRO+TAVR Systems against the
balloon-expandable SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart
Valves manufactured by Edwards Lifesciences.
Enrolling approximately 700 patients globally, the study will
evaluate valve performance in patients with small annuli and those
who are candidates for TAV-in-SAV procedures (transcatheter valve
implanted inside of a failed surgical valve), which combined,
represent more than 40% of the global TAVR market. Due to its focus
on small annulus patients, the SMART Trial will enroll
predominantly women, which will provide important clinical insight
into a currently underrepresented patient population in TAVR
literature. The study includes pre-specified endpoints of
hemodynamic (blood flow) superiority and clinical non-inferiority
with the Evolut platform for mortality, stroke, or
rehospitalization at 12 months.
"Hemodynamic performance is particularly important in many
patients with aortic stenosis, including those with small annuli,
surgical aortic valves needing a TAV-in-SAV procedure, patients
with left ventricular dysfunction, and those who are young and most
active. For many of these and other TAVR patients, valve design
matters," said Howard C. Herrmann,
M.D., the John Winthrop Bryfogle Professor of Cardiovascular
Diseases and director of interventional cardiology in the Perelman
School of Medicine at the University of
Pennsylvania, and principal investigator and chair of the
Steering Committee of the SMART Trial. "The outcome of this
important head-to-head study will allow heart teams to more
selectively tailor clinical decision making to ensure the right
valve is selected for the right patient." Dr. Herrmann has received
institutional research funding and financial compensation from
Edwards Lifesciences and Medtronic.
The first enrollment in the SMART Trial is targeted for early
2021.
Medtronic Evaluates TAVR in New Patient Populations
Medtronic also announced plans to begin a feasibility study of the
Evolut™ TAVR platform to evaluate the self-expanding, supra-annular
valve in patients with symptomatic moderate and asymptomatic severe
aortic stenosis, new patient populations outside of current
guidelines and indications for aortic valve replacement. The
Evolut™ EXPAND TAVR I Feasibility Study, which has been submitted
to the FDA for Investigational Device Exemption (IDE) approval,
would enroll up to 150 patients across both subgroups and evaluate
the use of TAVR in patients before signs of left ventricular
dysfunction are observed, and will assess the clinical and
hemodynamic performance of the Evolut TAVR system to inform future
clinical work.
"Moderate aortic stenosis, if left untreated, can be just as
deadly for patients as the more severe forms of the disease," said
Jeffrey Popma, M.D., chief medical
officer and vice president, medical affairs for the Structural
Heart business, which is part of the Cardiac and Vascular Group at
Medtronic. "Limited clinical research has shown that early
intervention may reduce the high rates of mortality often seen in
these patients as the disease progresses further down the road. The
outcomes observed from in this study will help shape our clinical
strategy to pursue expansion of the therapy to new populations who
may benefit."
More than 2 million patients live with symptomatic moderate and
asymptomatic aortic stenosis in the U.S., which represents more
than 40% of the total AS population in the U.S. Moderate AS remains
undertreated due to a lack of clinical evidence informing treatment
guidelines, while asymptomatic AS is undertreated due to the
absence of common symptoms that would indicate a heart valve
problem, such as shortness of breath, fatigue, dizziness, chest
pains or palpitations.
The Evolut TAVR platform – including the Evolut™ R, Evolut™ PRO
and Evolut™ PRO+ TAVR Systems – is indicated for symptomatic severe
AS patients across all risk categories (extreme, high, intermediate
and low) in the U.S. In addition, bicuspid aortic valve patients
across all risk categories may be candidates for TAVR in the
U.S.
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
90,000 people worldwide, serving physicians, hospitals and patients
in more than 150 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.
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SOURCE Medtronic plc