Medtronic Begins Enrollment in Feasibility Study of Valiant 'Mona LSA' Branch Thoracic Stent Graft System
April 21 2015 - 11:00AM
Investigational
Device Enables Endovascular Repair of
Aortic Aneurysms Encroaching on Left Subclavian Artery
DUBLIN -- April 21, 2015
-- Medtronic plc (NYSE: MDT) today announced
the start of a new feasibility study to evaluate the safety and
effectiveness of the Valiant Mona LSA branch thoracic stent graft
system, an investigational medical device designed to enable a
completely endovascular solution for aortic aneurysms encroaching
on the left subclavian artery (LSA).
Cleveland Clinic cardiothoracic surgeon Dr. Eric
Roselli successfully completed the first implant in the study on
Thursday. He serves as the study's national primary investigator
and receives consulting fees and honoraria for teaching from
Medtronic.
"Thoracic aortic aneurysms involving branch
vessels such as the LSA can be particularly challenging to treat,"
Dr. Roselli said. "The use of an off-the-shelf stent graft system
with a built-in branch has the potential to simplify this challenge
by eliminating the routine requirement for surgical LSA
bypass."
The study aims to enroll 24 subjects at up to
seven sites in the United States. The purpose of the study is
to characterize the safety and effectiveness of the investigational
device acutely and at 30 days.
The LSA branches off the arch of the aorta and
supplies oxygenated blood to the posterior brain and left arm.
Coverage of the LSA during endovascular repair of thoracic aortic
aneurysms proves necessary in about 40 percent of cases and is
associated with a higher rate of neurological complications,
according to published reports in peer-reviewed medical journals.
As a result, the Society for Vascular Surgery suggests routine
revascularization of the LSA in elective cases where achievement of
an adequate seal zone for the stent graft requires coverage of the
LSA.i
Based on the market-leading Valiant Captivia
thoracic stent graft system, which has been used to treat
approximately 50,000 patients worldwide over the last 10 years, the
Valiant Mona LSA system consists of two pieces -- a main graft for
placement in the aneurysmal segment of the aorta, and a branch
graft for placement in the LSA. In their deployed state, the
system's two pieces fit together to exclude the aneurysm and
maintain patency of the LSA. The main graft features a tapered
opening, or cuff, which is oriented toward the LSA. The branch
graft fits inside the cuff and terminates in the LSA.
"The start of this study represents another step
forward in our efforts to develop standardized stent graft systems
for the treatment of aortic disease involving branch vessels," said
Daveen Chopra, vice president and general manager of the Aortic
franchise in Medtronic's Aortic and Peripheral Vascular business.
"We remain committed to innovating safe and effective endovascular
solutions for these complex clinical challenges in support of
vascular interventionalists and their patients around the
world."
The Valiant Mona LSA system has previously been
studied as part of an early feasibility pilot program for medical
devices initiated by the U.S. Food and Drug Administration (FDA) in
2012. It was one of nine devices selected by the FDA for the
program. Results from this previous evaluation were presented at
the VEITHsymposium.
Use of the Valiant Mona LSA branch thoracic stent
graft system is limited to the current study approved by the U.S.
Food and Drug Administration (FDA) under an investigational device
exemption (IDE).
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 MEDTRONIC
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, is the global leader in medical technology -- alleviating
pain, restoring health and extending life for millions of people
around the world.
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 -
i The
Society for Vascular Surgery Practice Guidelines: Management of the
left subclavian artery with thoracic endovascular aortic repair. J
Vasc Surg 2009; 50:1155-8
Contacts:
Joe McGrath
Public Relations
+1-707-591-7367
Jeff Warren
Investor Relations
+1-763-505-2696
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Source: Medtronic plc via Globenewswire
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