CoreValve™ Evolut™ R
Recapturable and Repositionable Heart Valve Improves
Positioning Accuracy and Control During Deployment
BRAMPTON, ON, Oct. 22, 2016 /CNW/ - Medtronic Canada, a
subsidiary of Medtronic plc (NYSE: MDT), today announced
Health Canada licence of the new recapturable, self-expanding
CoreValve™ Evolut™ R System. The first and only recapturable and
repositionable device available in Canada, the CoreValve Evolut R System is
licenced for transcatheter aortic valve implantation (TAVI) in
severe aortic stenosis patients who are at high or extreme risk for
surgery. Untreated, aortic valve stenosis can lead to serious heart
problems including heart failure and even death.
Designed to treat patients with aortic stenosis, a condition
where the aortic valve narrows thereby limiting blood flow from the
aorta to the rest of the body, the CoreValve Evolut R System is
built on the proven foundation and procedural success of the
CoreValve System, which has been implanted in more than 75,000
patients in 60 countries.
The new system consists of the CoreValve Evolut R transcatheter
valve and the EnVeo™ R Delivery System, which features an InLine™
Sheath that significantly reduces the profile to the lowest on the
market (14 Fr equivalent, less than 1/5 inch). A smaller profile
size provides a greater opportunity to treat an expanded patient
population with smaller vessels (down to 5.0 mm), through the
preferred transfemoral access route, which may minimize the risk of
major vascular complications in some patients.
Based on the knowledge gained through the extensive experience
with the CoreValve System, the Evolut R is optimized to increase
conformability and sealing at the annulus, while maintaining
supra-annular valve positioning for improved blood flow and
hemodynamic performance. An extended sealing skirt on the 26mm and
29mm valve sizes is intended to further promote valve sealing at
the annulus.
"Obtaining a Health Canada licence for Evolut R marks a
significant milestone for Medtronic and TAVI, and ushers in a new
era in transcatheter aortic valves with advanced, recapturable
capabilities," said Michael
Blackwell, senior director of the CardioVascular Group at
Medtronic Canada. "This licence is an outcome of our commitment to
building a market‑leading innovation pipeline in the transcatheter
space, and we look forward to supporting heart teams as they look
to next-generation technologies that optimize valve performance for
a broad range of patients."
The licencing of Evolut R as the first self-expanding,
recapturable transcatheter heart valve available in Canada follows other significant milestones
reached over the past 18 months showcasing the company's leadership
in the TAVI market. Last year, the CoreValve System was the first
TAVI system to be licenced in Canada for valve-in-valve (VIV) procedures in
patients whose surgical aortic heart valves have failed. Also in
March 2015, the highly anticipated
two-year data from the High Risk Study of the CoreValve U.S.
Pivotal Trial was presented at the American College of Cardiology
2015, which showed superior survival benefit at two years for TAVI
with the CoreValve System compared to patients who underwent
surgical aortic valve replacement (SAVR).
In collaboration with leading clinicians, researchers and
scientists worldwide, Medtronic offers one of the broadest ranges
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 Canada (www.medtronic.ca), headquartered in
Brampton, Ontario is a subsidiary
of Medtronic plc, which 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 is proud to employ over 1,600 people in
Canada, serving physicians,
hospitals and patients across the country. 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
Medtronicʹs periodic reports on file with
the Securities and Exchange Commission. Actual results may
differ materially from anticipated results.
SOURCE Medtronic Canada