Medtronic Receives FDA Clearance for Riptide(TM) Aspiration System
January 16 2018 - 10:00AM
YASTEST
New System Expands
Neurovascular Product Portfolio
for the Treatment of Acute Ischemic Stroke
DUBLIN - January 16, 2018 -
Medtronic plc (NYSE:MDT) today announced that the company's
Neurovascular business unit received U.S. Food and Drug
Administration (FDA) clearance of the Riptide(TM) Aspiration
System, adding a valuable tool to the Acute Ischemic Stroke (AIS)
product portfolio.
The Riptide Aspiration System is designed to
retrieve thrombus (or blood clot) through the Arc(TM) Catheter and
restore blood flow in patients experiencing blockage of an artery
in the brain, known as an ischemic stroke. The procedure involves
inserting a catheter through an incision in the leg and up to the
blocked artery allowing the physician to remove the blood clot.
The Riptide Aspiration System is intended for use
in the revascularization of patients with acute ischemic stroke
secondary to intracranial large vessel occlusive disease (within
the internal carotid, middle cerebral - M1 and M2 segments, basilar
and vertebral arteries) within eight (8) hours of symptom onset.
Patients who are ineligible for intravenous tissue plasminogen
activator (IV t-PA) or who fail IV t-PA therapy are candidates for
treatment.
"While I primarily use the
Solitaire(TM) Revascularization Device to treat patients with
acute ischemic stroke, I utilize a direct aspiration approach as my
first line treatment strategy in select circumstances such as
basilar artery thromboembolism and in select anterior circulation
cases," said Dr. Daniel Sahlein, interventional
neuroradiologist, Goodman Campbell Brain and Spine, assistant
professor of clinical neurology in the department of Neurological
Surgery, Indianapolis University-Purdue University
Indianapolis. "The Riptide Aspiration System will provide me
with another proven Medtronic product to utilize when treating
stroke patients."
The Riptide Aspiration System includes the Arc
Catheter, RiptideAspiration Tubing, Riptide Aspiration Pump and
RiptideCollection Canister with intermediate tubing. The Riptide
Aspiration System is a foundational platform for future aspiration
catheters, currently in development.
"Medtronic is committed to developing services and
solutions that address healthcare needs by improving clinical and
economic outcomes," said Stacey Pugh, vice president and general
manager of Medtronic's Neurovascular business which is part of the
Restorative Therapies Group. "We believe that the Riptide
Aspiration System and SolitaireRevascularization Device provide our
customers with a comprehensive suite of products to choose
from. Medtronic is committed to being a complete solutions
provider in the treatment of Acute Ischemic Stroke market."
According to the American Heart
Association/American Stroke Association (AHA/ASA), stroke is the
fifth leading cause of death in the U.S. and a leading cause of
disability.1 In June 2015,
the AHA/ASA published new stroke treatment guidelines that
recommended the use of stent retriever technology - such as the
Solitaire stent retriever device - in conjunction with IV
rtPA/alteplase as a first-line treatment for eligible
patients.2
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-
Sources:
-
American Heart Association Media Alert: Stroke
falls to No. 5 cause of death in the U.S. Available at:
http://newsroom.heart.org/news/stroke-falls-to-no-5-cause-of-death-in-u-s.
Accessed January 8, 2018.
-
2015 American Heart Association/American Stroke
Association Focused Update of the 2013 Guidelines for the Early
Management of Patients With Acute Ischemic Stroke Regarding
Endovascular Treatment. Available at:
http://stroke.ahajournals.org/content/early/2015/06/26/STR.0000000000000074.
Published June 29, 2015. Accessed January 8, 2018.
Contacts:
David T. Young
Public Relations
+1-774-284-2746
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
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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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