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 The leading web portal for pharmacy resources, news, education and careers April 20, 2019
Pharmacy Choice - Pharmaceutical News - Medtronic Receives FDA Approval on Expanded Indication for Pipeline Flex Embolization Device - April 20, 2019

Pharmacy News Article

 2/7/19 - Medtronic Receives FDA Approval on Expanded Indication for Pipeline Flex Embolization Device

Approval Based on Clinical Data from the PREMIER Trial - New Indication Provides
     Options for Patients with Small or Medium, Wide-Necked Brain Aneurysms

DUBLIN - February 7, 2019 - Medtronic plc (NYSE:MDT) announced today that it has
received U.S. Food and Drug Administration (FDA) approval on an expanded
indication for its Pipeline(TM) Flex embolization device.(1) Previously
indicated for the endovascular treatment of adults with large or giant wide-
necked intracranial aneurysms (IAs) in the internal carotid artery from the
petrous to the superior hypophyseal segments, the new indication opens options
for patients with small or medium, wide-necked brain aneurysms in the territory
from the petrous to the terminus of the internal carotid artery.

An estimated 500,000 people throughout the world die each year due to ruptured
brain aneurysms, with half the victims younger than 50 years of age.(2)

Approval was based on clinical data from the Prospective Study on Embolization
of Intracranial aneurysms with the Pipeline(TM) Device (PREMIER) trial, which
expands understanding of the safety and efficacy for this device for a broader
patient population. A total of 141 subjects with a mean aneurysm size of
5.01.92 mm were analyzed. Data showed one-year occlusion rates of 76.7 percent
with the use of 1.1 device per subject on average and a 2.2 percent occurrence
of major stroke or neurological death.(3)

"PREMIER is another landmark study with Pipeline and moves the bar on the safe
treatment of wide-necked brain aneurysms," said Dr. Ricardo Hanel, neurosurgeon,
director of Stroke and Cerebrovascular Center at Baptist Health in Jacksonville,
Fla., and principal investigator for the PREMIER trial. "This data changes the
way we, as physicians, think about using Pipeline Flex to treat our patients."

Designed to divert blood flow away from an aneurysm, the Pipeline Flex
embolization device features a braided cylindrical mesh tube that is implanted
across the base or neck of the aneurysm. The device cuts off blood flow to the
aneurysm, reconstructing the diseased section of the parent vessel. This is the
second Investigational Device Exemption (IDE) study for this implant which
gained FDA approval after completing the 'Pipeline for Uncoilable or Failed
aneurysms' (PUFs) trial, a 5-year study for large and giant wide-necked
aneurysms of the intracranial internal carotid artery (ICA) where efficacy rates
were reported at 70.8 percent at 1 year that progressed to 95 percent in
subjects with angiographic follow up at the 5 year time period. In the PUFs
study the overall occurrence of major stroke or neurological death was 5.6
percent(4). There were no documented cases of aneurysm recurrence in patients
treated with the implant.

"Working hand-in-hand with physicians to develop new technology and clinical
data is at the core of our mission. The PREMIER study not only demonstrated
excellent safety and efficacy outcomes but also delivered on our commitment to
broadening access to innovative therapies for new groups of patients requiring
aneurysm treatment," said Stacey Pugh, vice president and general manager of the
Neurovascular business, which is part of the Restorative Therapies Group at

In the United States, the Pipeline Flex device is intended for use for the
endovascular treatment of complex wide-necked intracranial aneurysms located in
the ICA, attached to parent vessels measuring between 2.0 and 5.0 mm in

Flow diversion has been used to treat patients in the United States since 2011.
This product is part of the Neurovascular portfolio in Medtronic's Restorative
Therapies Group.

Medtronic Neurovascular's Pipeline(TM) Flex
embolization device received FDA approval of
an indication expansion for patients with small
or medium, wide-necked brain aneurysms.
Click the thumbnail above for a larger image.

About Medtronic
Medtronic plc (, 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 86,000 people worldwide, serving
physicians, hospitals, and patients in more than 150 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


1. PMA- P100018-S015
2. Brain Aneurysm Statistics and Facts. (2019, January 16).
3. PREMIER Clinical Study Report Medtronic FD3563, mITT Population, Rev
B. 12-SEP-2018
4. Becske T. et al., Long-Term Clinical and Angiographic Outcomes
Following Pipeline Embolization Device Treatment of Complex Internal Carotid
Artery Aneurysms: Five-Year Results of the Pipeline for Uncoilable or Failed
Aneurysms Trial., (JNS) Neurosurgery Published online Jan 9, 2017

David T. Young
Public Relations

Ryan Weispfenning
Investor Relations

This announcement is distributed by West Corporation on behalf of West Corporation 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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