Medtronic Endurant(TM) II/IIs Stent Graft System Receives FDA Approval to Treat Short Neck Anatomies When Used with Heli-FX(T...
October 09 2017 - 7:00AM
YASTEST
New Indication
Expands Treatment Options for AAA Patients with Hostile Neck
Anatomy
DUBLIN - October 9, 2017 -
Medtronic plc (NYSE: MDT) today announced that it has received U.S.
Food and Drug Administration (FDA) approval for the Endurant(TM)
II/IIs stent graft system to treat abdominal aortic aneurysm (AAA)
patients with neck lengths down to 4mm and <=60° infra-renal
angulation when used in combination with the Heli-FX(TM)
EndoAnchor(TM) system. The expanded indication enables the Endurant
II/IIs stent graft to be used in conjunction with the Heli-FX
EndoAnchor system to treat a wider range of patients with short,
hostile aortic neck anatomies, independent of renal stenting.
Until now, some patients with short infra-renal
necks (<10mm) were considered ineligible for endovascular
aneurysm repair (EVAR), leaving them with limited treatment
options. Up to 30 to 40 percent of patients with AAA disease are
considered unsuitable candidates for conventional
EVAR.1 According to estimates from physicians across Europe
and the United States, more than one-third of these patients have
AAA proximal neck anatomies <= 10mm.2
"Due to the complex and hostile proximal aortic
neck anatomy, this patient population remains a challenge to
treat," said William Jordan, Jr., M.D., professor of surgery and
chief, Division of Vascular Surgery and Endovascular Therapy at
Emory University School of Medicine and co-principal investigator
of the ANCHOR registry. "With minimal time added to the procedure,
EndoAnchor fixation has been proven to enhance outcomes and
durability, establishing a new treatment approach that addresses
this critical patient need."
The FDA approval is supported by a short neck
cohort of the ANCHOR registry, a global multi-center, multi-arm,
prospective, post-market registry evaluating the real-world
applicability of the Heli-FX EndoAnchor system. Led by co-principal
investigators Dr. Jordan and Jean-Paul de Vries, M.D., chief of
Vascular Surgery at St. Antonious Hospital in Nieuwegein, the
Netherlands, outcomes from a sub-analysis of 70 patients with
proximal AAA neck lengths <10mm down to 4mm who were treated
with Endurant and Heli-FX demonstrated a technical success rate of
88.6 percent, based on delivery and deployment of the stent graft
and each EndoAnchor implant used, and a 97.1 percent procedural
success rate (investigator-assessed), with a rate of 1.9 percent
proximal type Ia endoleaks at one year. Additionally, there was
only one type Ia endoleak that resulted in a secondary procedure
through one year.
At one year there were no AAA expansions or
instances of main body migration and through one year, no instances
of AAA ruptures. There was minimal EndoAnchor implant time added to
the overall procedure, with an average of 17 minutes.
"The acquisition of Aptus Endosystems in 2015
demonstrated our deep-rooted commitment to investing in solutions
that treat complex aortic disease, and this new indication
expansion for the Endurant II/IIs stent graft system is a
significant milestone that underscores our promise to improve
patient outcomes in partnership with the clinician community," said
Daveen Chopra, vice president and general manager of the Aortic
business, which is part of the Aortic & Peripheral Vascular
division at Medtronic. "With the use of the Heli-FX Endoanchor
system, physicians can now provide durable seal and fixation with a
proven stent graft technology to expand care to patients with
hostile neck anatomies."
About the Endurant(TM) II/IIs
Stent Graft System
The Endurant II/IIs stent graft system is based on the leading
Medtronic Endurant stent graft system, which is selected for nearly
one of every two endovascular AAA repairs globally resulting in
nearly 300,000 successful implants. The original Endurant system
received the CE (Conformité Européenne) Mark
in June 2008 and approval from the FDA in December 2010. The
Endurant II/IIs stent system is approved in the U.S. for neck
lengths >=10 mm and <=60° infra-renal angulation. With the
new indication expansion, Endurant with Heli-FX EndoAnchor system
has been approved by the FDA for use in patients with shorter neck
lengths (less than 10mm down to 4mm).
Additionally, in December 2016, Medtronic received
CE Mark for the Endurant(TM) II/IIs stent graft system to treat
abdominal aortic aneurysm (AAA) patients using a ChEVAR
procedure.
About the Heli-FX and Heli-FX(TM)
Thoracic EndoAnchor Systems
The Medtronic Heli-FX and Heli-FX Thoracic EndoAnchor systems
feature an endovascular-deployed anchor designed to attach a
variety of aortic endografts to the native vessel wall. This
off-the-shelf, customized solution minimizes the need for
complicated procedures for the select subset of patients who would
benefit from supplementary fixation including patients with
challenging anatomies, risk factors for a secondary intervention,
existing seal complications, as well as in situations where a
physician may intraoperatively determine the need for additional
security.
The Heli-FX system is cleared by the FDA for
distribution in the U.S. and has been granted CE Mark for
distribution in the European Union. Both products are also
commercialized in other countries worldwide. The Heli-FX EndoAnchor
system can be used with a wide variety of commercially available
stent grafts, including the Medtronic Endurant and Valiant(TM)
stent graft systems.
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 of the highest quality 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 84,000 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-
1Skelly, Christopher L., and Ross Milner.
Difficult Decisions in Vascular Surgery: an Evidence-Based
Approach. Springer, 2017.
2Medtronic data on file.
Contacts:
Krystin Hayward Leong
Public Relations
+1-508-261-6512
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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information contained therein.
Source: Medtronic plc via Globenewswire
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