ALAMEDA,
Calif., Oct. 14, 2024 /PRNewswire/ -- Penumbra,
Inc. (NYSE: PEN), the world's leading thrombectomy company,
announced the completion of enrollment in its THUNDER clinical
study for patients with acute ischemic stroke. THUNDER is
evaluating the safety and efficacy of the company's latest computer
assisted vacuum thrombectomy (CAVT™) technology, Penumbra System™
with Thunderbolt™ Aspiration Tubing, for the removal of blood clots
in the brain.
"This critical milestone brings us another step closer to
providing physicians with the latest technology for stroke
management," said Adam Elsesser,
president and chief executive officer of Penumbra. "The THUNDER
study will provide the data set needed to evaluate Penumbra's
Thunderbolt technology and I am optimistic that we are at the dawn
of a new era in stroke treatment."
Penumbra System with Thunderbolt Aspiration Tubing uses an
advanced CAVT software algorithm to generate proprietary modulated
aspiration, reducing friction between the clot and reperfusion
catheter and facilitating a more rapid and complete removal of
blood clots in the brain. Thunderbolt Aspiration Tubing has been
designed for use with Penumbra ENGINE™ and RED™ reperfusion
catheters.
The THUNDER study (NCT05437055) is a multi-center, single-arm
study evaluating patients with acute ischemic stroke secondary to
intracranial large vessel occlusion (LVO) who are eligible for
mechanical thrombectomy. The primary efficacy endpoint includes
revascularization of the occluded target vessel at immediate
post-procedure.
About Penumbra
Penumbra Inc., the world's
leading thrombectomy company, is focused on developing
the most innovative technologies for challenging medical conditions
such as ischemic stroke,
venous thromboembolism such as pulmonary embolism, and
acute limb ischemia. Its broad portfolio, which includes
computer assisted vacuum thrombectomy (CAVT), centers on
removing blood clots from head-to-toe with speed, safety and
simplicity. By pioneering these innovations, Penumbra supports
healthcare providers, hospitals and clinics in more than 100
countries, working to improve patient outcomes and quality of life.
For more information, visit www.penumbrainc.com and
connect on Instagram, LinkedIn and X.
Important Safety Information
Additional information
about Penumbra's products can be located on Penumbra's website at
https://www.penumbrainc.com/providers. Prior to use, please refer
to Instructions for Use for complete product indications,
contraindications, warnings, precautions, potential adverse events
and detailed instructions for use. Risk information can be found at
http://www.peninc.info/risk.
Forward-Looking Statements
Except for historical
information, certain statements in this press release are
forward-looking in nature and are subject to risks, uncertainties
and assumptions about us. Our business and operations are subject
to a variety of risks and uncertainties and, consequently, actual
results may differ materially from those projected by any
forward-looking statements. Factors that could cause actual results
to differ from those projected include, but are not limited to:
failure to sustain or grow profitability or generate positive cash
flows; failure to effectively introduce and market new products;
delays in product introductions; significant competition; inability
to further penetrate our current customer base, expand our user
base and increase the frequency of use of our products by our
customers; inability to achieve or maintain satisfactory pricing
and margins; manufacturing difficulties; permanent write-downs or
write-offs of our inventory or other assets; product defects or
failures; unfavorable outcomes in clinical trials; inability to
maintain our culture as we grow; fluctuations in foreign currency
exchange rates; potential adverse regulatory actions; and the
potential impact of any acquisitions, mergers, dispositions, joint
ventures or investments we may make. These risks and uncertainties,
as well as others, are discussed in greater detail in our filings
with the Securities and Exchange Commission (SEC), including our
Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on
February 22, 2024. There may be
additional risks of which we are not presently aware or that we
currently believe are immaterial which could have an adverse impact
on our business. Any forward-looking statements are based on our
current expectations, estimates and assumptions regarding future
events and are applicable only as of the dates of such statements.
We make no commitment to revise or update any forward-looking
statements in order to reflect events or circumstances that may
change.
Contact
|
|
Jennifer
Heth
|
Parinaz
Farzin
|
Penumbra,
Inc.
|
Merryman
Communications
|
jheth@penumbrainc.com
|
parinaz@merrymancommunications.com
|
510-995-9791
|
310.600.6746
|
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SOURCE Penumbra, Inc.