Medtronic's Endurant(TM) II/IIs Stent Graft System Receives CE Mark for Use with ChEVAR Parallel Graft Technique
December 06 2016 - 5:00AM
Medtronic is First
and Only Company to Receive Approval for a ChEVAR Indication,
Providing an Off-the-Shelf Option for Patients with Complex
Aneurysms
DUBLIN - Dec. 6, 2016 -
Medtronic plc (NYSE:MDT) today announced that it has received CE
(Conformité Européenne) Mark for the
Endurant(TM) II/IIs stent graft system to treat abdominal aortic
aneurysm (AAA) patients using a ChEVAR procedure, a parallel graft
chimney technique that uses commercially available balloon
expandable covered stents combined with a standard aortic stent
graft. This expanded indication in the European Union enables the
Endurant II/IIs stent graft system to be used in patients with
complex aneurysms with short aortic neck lengths >=2 mm,
expanded from the prior neck length indication >=10 mm.
"Treating aneurysm patients with short aortic
necks has been a long-time challenge for clinicians performing
endovascular aneurysm repair (EVAR) to treat AAA patients," said
Professor Giovanni B. Torsello, M.D., chief of Vascular Surgery,
St. Franzkisus Hospital, Münster, Germany and co-author of the
PROTAGORAS study. "The availability of a standardized approach
which increases anatomical applicability will help establish a new
standard for patients with complex forms of AAA that may not have
been suited for previous procedures."
The CE Mark is supported by a comprehensive review
of clinical data from literature using the Endurant II/IIs stent
graft system with the ChEVAR technique. In the flagship PROTAGORAS
study, outcomes were tracked with radiologic follow up over a mean
of two years. The study used a standardized procedural approach
with the Endurant system and balloon expandable covered stents. The
results, which were published in the Journal of Vascular Surgery,
demonstrated that standardized use of the Endurant II/IIs stent
graft system with ChEVAR in 128 patients is associated with 100
percent technical success, statistically significant aneurysm sac
regression (p = .001), 95.7 percent primary patency of the chimney
grafts and a low incidence of chimney related
reinterventions.1,2
"Medtronic is committed to partnering with our
clinical community to provide solutions for challenging patients
with complex aortic disease," said Daveen Chopra, vice president
and general manager of the Aortic business, which is part of the
Aortic & Peripheral Vascular division at Medtronic. "The
expanded indication for our Endurant II/IIs stent graft system is a
great example of how we can deliver solutions to address unmet
clinical needs and improve standard of care for patients who have
aneurysms with short neck lengths. We are excited to expand our
leadership in EVAR with the first aortic stent graft approved for
use with the ChEVAR technique."
The Endurant II/IIs stent graft system is based on
Medtronic's leading Endurant stent graft system, which is selected
for nearly one of every two endovascular AAA repairs globally and
has resulted in more than 250,000 successful implants. The original
Endurant system received the CE (Conformité
Européenne) Mark in June 2008. The new expanded ChEVAR
indication will be initially commercialized in Europe, and then in
other countries that recognize the CE Mark approval. In
the U.S., Food and Drug Administration approval for the Endurant
Stent Graft System was granted in December 2010. In the U.S.,
the Endurant II/IIs stent system is approved for neck lengths
>=10 mm and <=60° infra-renal angulation and it is not
approved for this expanded indication.
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 approximately 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-
1 Donas,
K. P. et al. The PROTAGORAS study to evaluate the performance of
the Endurant stent graft for patients with pararenal pathologic
processes treated by the chimney/snorkel endovascular technique.
Journal of Vascular Surgery, Volume 63, 1 - 7.
2 Freedom from
chimney graft-related reinterventions was 93.1 percent.
Contacts:
Krystin Hayward
Public Relations
+1-508-298-8246
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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Source: Medtronic plc via Globenewswire
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