Data from ANCHOR
Registry Demonstrate Applicability in Patients with Hostile Aortic
Neck Anatomy
DUBLIN and NEW YORK - Nov. 17,
2016 - Medtronic plc (NYSE: MDT) today announced data
demonstrating that the company's Heli-FX(TM) EndoAnchor(TM) system
enhances outcomes and durability in patients with complex aortic
abdominal aneurysm (AAA) anatomy, particularly those who have
hostile aortic neck anatomy. The new data were presented in a
series of three different presentations during the 43rd Annual
Symposium of Vascular and Endovascular Issues (VEITHsymposium) in
New York. The findings are based on new sub-analyses from
Medtronic's ANCHOR registry - a global, multi-center, multi-arm,
prospective, post-market registry evaluating the real-world
applicability of the Heli-FX EndoAnchor System in up to 2,000
patients.
ANCHOR Propensity
Analysis
Data presented for the first time by Bart Muhs, M.D., Ph.D., a
vascular surgeon at The Vascular Experts in Middletown, Conn.,
demonstrated outcomes in 99 patients who received EndoAnchor
implants with the Heli-FX EndoAnchor system along with an approved
stent graft during an endovascular aneurysm repair (EVAR) compared
with 99 patients who did not receive EndoAnchor implants during
EVAR.
Patients in both arms of the ANCHOR propensity
analysis (a statistical analysis of observational data) were
matched using 19 anatomical and physiological baseline
variables.
After a mean follow up of over one year, patients
in the ANCHOR test group experienced:
While not statistically significant, the results
also showed:
-
Less proximal neck dilation: freedom from neck
dilation was 98.4 percent in the EndoAnchor test group versus 94.9
percent in the control group.
-
Encouraging low rates of Type Ia endoleaks (an
endoleak characterized by a poor seal): freedom from Type 1a
endoleak in the EndoAnchor test group was 97.0 percent versus 94.1
percent in the control group.
"This propensity matched data from the ANCHOR
registry shows that the Heli-FX EndoAnchor system improves patient
outcomes based on key measures of effectiveness," said Dr.
Muhs. "Our analysis reflects real-world clinical experience,
and provides the next level of clinical evidence supporting this
EndoAnchor system in patients with complex, hostile abdominal
aortic aneurysms."
ANCHOR Registry
Additional follow up data up from the ANCHOR registry were
presented by William Jordan, M.D., professor of surgery and chief,
division of vascular surgery and endovascular therapy at Emory
University School of Medicine. The data, based on follow up of 604
patients, showed the Heli-FX EndoAnchor system provides additional
security when used with approved endovascular stent grafts in
patients with hostile AAAs. Patients were evaluated in three groups
who either received the Heli-FX EndoAnchor System prophylactically
at the same time as an EVAR procedure (n= 314), as a therapeutic
primary for a Type Ia endoleak occurring immediately after the EVAR
(n=123), or as a therapeutic revision during a follow-up visit to
treat a post-EVAR complication (n=167).
In all three groups, patients had very short
necks, indicative of the hostile anatomy: median neck length was
11.5mm in the prophylactic group and 12.1mm in the therapeutic
primary and 10.2mm in the therapeutic revision group. Specific
results evaluated by a core laboratory at one and two years for all
three groups include:
-
Favorably low rates of Type Ia endoleaks:
-
One year: prophylactic = 0.6 percent;
therapeutic primary = 1.4 percent; therapeutic revision = 19.2
percent
-
Two years: prophylactic = 0.0 percent ;
therapeutic primary =2.9 percent; therapeutic revision 11.1
percent
-
Positive sac regression despite the hostile
anatomy characteristics:
-
One year: prophylactic = 45.6 percent;
therapeutic primary = 43.1 percent; therapeutic revision = 16.9
percent
-
Two years: prophylactic = 61.2 percent;
therapeutic primary = 51.4 percent; therapeutic revision = 37.9
percent
-
High rates of freedom from secondary
procedures:
-
One year: prophylactic = 95.9 percent;
therapeutic primary = 97.9 percent; therapeutic revision = 84.8
percent
-
Two years: prophylactic = 92.1 percent;
therapeutic primary = 92.9 percent; therapeutic revision = 79.9
percent
-
High rates of freedom from aneurysm related
mortality (ARM), which is notable given the short neck
lengths:
-
One year: prophylactic = 98.4 percent;
therapeutic primary = 98.4 percent; therapeutic revision = 96.5
percent
-
Two years: prophylactic = 98.4 percent;
therapeutic primary = 98.4 percent; therapeutic revision = 92.6
percent
"These data further support the added security and
durability of the Heli-FX EndoAnchor System we are seeing in
clinical practice," said Dr. Jordan. "With low rates of Type Ia
endoleaks and re-intervention rates, positive sac regression and
freedom from ARM rates, EndoAnchor implants allow for safe and
effective treatment of more complex anatomies, both
prophylactically and in conjunction with treatment of a post-EVAR
complication, such as a migration or Type Ia endoleak."
In a related presentation, Apostolos Tassiopoulos,
M.D., department of surgery, division of vascular and endovascular
surgery, Stony Brook University Medical Center, N.Y., presented
data demonstrating effects of Heli-FX EndoAnchor system on neck
dilation. This additional data from the ANCHOR registry
characterized several variables predictive of perioperative neck
dilation. The analysis showed that after one year, EndoAnchor
implants appear to offer protection against neck dilation.
"We are excited to see the continued, positive
data from the ANCHOR registry that demonstrate the strength and
durability of our Heli-FX EndoAnchor system when used with EVAR in
patients with hostile AAA anatomy," said Daveen Chopra, vice
president and general manager of the Aortic business, which is part
of the Aortic & Peripheral Vascular division at Medtronic.
"Following our acquisition of Aptus Endosystems and its Heli-FX and
Heli-FX Thoracic EndoAnchor systems last year, this technology
further reflects our commitment in providing solutions for
challenging patients with complex aortic disease based on
real-world, rigorous clinical data."
Medtronic's Heli-FX
EndoAnchorSystems
Medtronic's Heli-FX and Heli-FX(TM) Thoracic EndoAnchor(TM) 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. This may include 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 and Heli-FX Thoracic EndoAnchor
systems are cleared by the FDA for distribution in the United
States and have been granted CE Mark for distribution in the
European Union. Both products are also commercialized in other
countries worldwide. The Heli-FX and Heli-FX Thoracic EndoAnchor
systems can be used with a wide variety of commercially available
stent grafts, including Medtronic's Endurant® and Valiant® stent
graft systems. Medtronic also plans to pursue approval for use of
the Heli-FX EndoAnchor system in patients with infrarenal proximal
necks <10mm.
In collaboration with leading clinicians,
researchers, and scientists, Medtronic offers the broadest range of
innovative medical technology for the interventional and surgical
treatment of cardiovascular diseases and cardiac arrhythmias. The
company strives to offer products and services that deliver
clinical and economic value to healthcare consumers and providers
worldwide.
About
VEITHsymposium
Now in its 43rd year, VEITHsymposium provides vascular surgeons,
interventional radiologists, interventional cardiologists, and
other vascular specialists with a unique and exciting format to
learn the most current information about what is new and important
in the treatment of vascular disease. The 5-day event features
rapid-fire presentations from world renowned vascular specialists
with emphasis on the latest advances, changing concepts in
diagnosis and management, pressing controversies and new
techniques. Press will receive complimentary registration. Please
visit www.VEITHpress.org or contact Pauline T. Mayer at
+1-561-316-3330.
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-
Contacts:
Krystin Hayward
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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