Medtronic's Endurant(TM) II/IIs Stent Graft System Receives CE Mark for Use with ChEVAR Parallel Graft Technique
(Thomson Reuters ONE) -
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
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Medtronic plc via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 06.12.2016 - 12:00 Uhr
Sprache: Deutsch
News-ID 511167
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