First Patient Treated with Medtronic Valiant TAAA Stent Graft System in Thoracoabdominal Aortic Aneurysm Study
February 09 2016 - 10:00AM
Sanford Health in
Collaboration with Medtronic Leads Global Efforts to Address
Challenging Vascular Condition
DUBLIN and SIOUX FALLS, S.D. -
February 9, 2016 - Medtronic plc (NYSE:MDT), a global leader in
medical technology, services and solutions and Sanford Health, one
of the nation's largest health care systems, today announced the
first patient enrolled in a clinical study using the Medtronic
Valiant® TAAA Stent Graft System for minimally invasive repair of
thoracoabdominal aortic aneurysm.
An aortic aneurysm is a dangerous bulge or
ballooning in a segment of the wall of the aorta that can rupture
and cause sudden death if left untreated. Thoracoabdominal aortic
aneurysms start in the chest and extend through the abdomen, and
represent about 15 percent of all thoracic aneurysms. The
aneurysms typically involve the branch arteries that supply blood
to multiple internal organs. Historically this challenging anatomy
has been treated with a complex open surgical procedure that is
associated with high morbidity and mortality.
The procedure was performed by Patrick
Kelly, M.D., through a physician sponsored, investigational device
exemption (PS-IDE - NCT02294435), approved by the U.S. Food and
Drug Administration (FDA). Dr. Kelly, a physician and inventor who
leads Sanford Vascular Innovations, reports the patient was a
58-year-old female with few alternative medical options for
treatment of her aneurysm.
"The mortality rate is 25 percent when treating a
thoracoabdominal aortic aneurysm with an open surgical technique,
which involves cutting open the aorta. Providing the patient with
an option for a less-invasive approach is needed," said Dr.
Kelly. "This procedure marked an important step in the
process to obtain FDA approval, and Sanford's support of such
innovation will give hope to patients afflicted with challenging
disease states such as this."
The Valiant TAAA Stent Graft System is intended to
allow for an off-the-shelf endovascular solution to one of
surgery's most difficult pathologies. The device garners
broad attention as physicians search for options to treat patients
with severe and challenging aortic disease.
"The Valiant TAAA approach allows for the
procedure to be staged at any time and lets the operator work on
each branch vessel individually," said James Black III, M.D., chief
of the Division of Vascular Surgery and Endovascular Therapy at
Johns Hopkins Hospital. "When taking on challenging cases, the
device leverages skill sets that are quite routine for vascular
surgeons."
"The novel device is customizable and diverse,"
said Thomas Naslund, M.D., chief of the Division of Vascular
Surgery at Vanderbilt University Medical Center. "It's critical
that our field focus on innovative ways to treat these kinds of
aneurysms."
"As the first patient treated with the minimally
invasive Valiant TAAA recovers, we are inspired by the innovators
that continue to challenge the limitations of current treatment
options," said Daveen Chopra, vice president and general manager of
the Aortic business, which is part of the Aortic & Peripheral
Vascular division at Medtronic. "Our mission to improve patient
outcomes will drive us into the future as we seek to treat more
complex aortic disease."
A concept for the novel Valiant TAAA system was
first described in the November 2014 issue of the Journal of
Vascular Surgery. Dr. Kelly developed the
concept for the system and has since collaborated with Medtronic.
Sanford Health holds the intellectual property covered by the
exclusive patent license agreement with Medtronic. Medtronic plans
to study the system in collaboration with physicians at several
medical centers, including Dr. Kelly at Sanford Health.
Medtronic is the long-standing leader in medical
technology for endovascular aortic repair. Nearly one in every two
endovascular aortic repairs performed worldwide are done with a
Medtronic product.
About Sanford
Health
Sanford Health is an integrated health system headquartered in the
Dakotas. It is one of the largest health systems in the nation with
43 hospitals and nearly 250 clinics in nine states and four
countries. Sanford Health's 27,000 employees, including 1,400
physicians, make it the largest employer in the Dakotas. Nearly $1
billion in gifts from philanthropist Denny Sanford have allowed for
several initiatives, including global children's clinics, genomic
medicine and specialized centers researching cures for type 1
diabetes, breast cancer and other diseases. For more information,
visit sanfordhealth.org.
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 85,000 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:
Kena Hudson
Medtronic Public Relations
+1-510-246-0163
Ryan Weispfenning
Medtronic Investor Relations
+1-763-505-4626
Tim Gerszewski
Sanford Media Strategist
+1-605-366-2432
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX 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
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