Latest Data Demonstrates Penumbra System and RED® Reperfusion Catheters Effective for Broad Stroke Care
25 August 2022 - 3:00PM
Business Wire
- Initial INSIGHT Registry data demonstrated RED® reperfusion
catheters were highly effective in removing all clot types with an
impressive 68.9% mTICI > 2b-3
overall first pass effect rate
- COMPLETE study sub-analyses of tandem lesions and late window
showed aspiration thrombectomy with Penumbra System® restored
blood flow and resulted in improved 90-day functional outcomes
Penumbra, Inc. (NYSE: PEN), a global healthcare company focused
on innovative therapies, announced initial INSIGHT Registry data
showing Penumbra’s RED® reperfusion catheters were successful in
removing all clot types. Additionally, results of sub-analyses of
the COMPLETE study showed use of the Penumbra System is effective
for acute ischemic stroke (AIS) patients with tandem lesions, as
well as patients who are considered in the late window of
treatment. The results were presented at the 2022 World Federation
of Interventional and Therapeutic Neuroradiology (WFITN) in Kyoto,
Japan.
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Penumbra, Inc. (NYSE: PEN), a global
healthcare company focused on innovative therapies, announced
initial INSIGHT Registry data showing Penumbra’s RED® reperfusion
catheters were successful in removing all clot types. Additionally,
results of sub-analyses of the COMPLETE study showed use of the
Penumbra System is effective for acute ischemic stroke (AIS)
patients with tandem lesions, as well as patients who are
considered in the late window of treatment. The results were
presented at the 2022 World Federation of Interventional and
Therapeutic Neuroradiology (WFITN) in Kyoto, Japan. (Photo:
Penumbra, Inc.)
“The initial data from our INSIGHT Registry is very promising.
With such a high first pass rate, Penumbra’s RED catheters can
restore blood flow much quicker, which we know can lead to improved
outcomes for patients,” said Sandra Lesenfants, president of
interventional at Penumbra, Inc. “Penumbra’s focus has always been
to help as many people as we can, and this data demonstrates that
our latest technology is indeed making a positive impact.”
The initial INSIGHT Registry data evaluating Penumbra’s latest
RED reperfusion catheters in 161 AIS patients showed 68.9% had
successful first-pass revascularization (mTICI≥2b-3), and 97.0% had
successful revascularization after final angiogram through site
reported findings. Final mTICI≥2b-3 scores were reported in 98.1%
of patients with firm-red clots and in 100% of patients with other
clot types. The INSIGHT Registry is a multicenter post-market
evaluation.
“Mechanical aspiration thrombectomy is becoming an increasingly
important option for physicians treating acute ischemic stroke,
especially patients with more complicated cases,” said Osama
Zaidat, M.D., the National Principal Investigator of the COMPLETE
study. “Oftentimes, patients that presented late or have tandem
lesions (15% of MT cases) are difficult to treat. However, the data
showed the Penumbra System delivered good functional outcomes and
low 90-day mortality rates for these patients, which compared
favorably to other options.”
COMPLETE is a global, prospective, multicenter post-market study
assessing the performance of the company’s Penumbra System. The
Core Lab adjudicated findings include:
- Patients with anterior circulation tandem lesions with stenosis
greater than 50% treated with Penumbra System resulted in
successful revascularization: 89% of patients achieved mTICI 2b-3
and nearly 64% of patients achieved 90-day mRS 0-2.
- Late window patients achieved successful revascularization with
the use of the Penumbra System in 83.2% of cases, with a 90-day
good functional outcome rate of 55.4%. Additionally, there were no
device related adverse events observed.
“The presented data confirms that Penumbra’s aspiration
thrombectomy innovations are highly effective. Our drive to advance
novel technologies allows us to provide physicians with the
broadest portfolio of proven solutions for stroke management,”
continued Lesenfants.
About Penumbra
Penumbra, Inc., headquartered in Alameda, California, is a
global healthcare company focused on innovative therapies. Penumbra
designs, develops, manufactures and markets novel products and has
a broad portfolio that addresses challenging medical conditions in
markets with significant unmet need. Penumbra supports healthcare
providers, hospitals and clinics in more than 100 countries. For
more information, visit www.penumbrainc.com and connect on Twitter
and LinkedIn.
Important Safety Information
Additional information about Penumbra’s products can be located
on Penumbra’s website at
http://www.penumbrainc.com/healthcare-professionals. 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 here.
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: the impact of the COVID-19 pandemic on our
business, results of operations and financial condition; 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; 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, including our Annual Report on Form 10-K for the year
ended December 31, 2021 filed with the SEC on February 22, 2022.
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.
Source: Penumbra, Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20220825005260/en/
Jennifer Heth Penumbra, Inc jheth@penumbrainc.com
510-995-9791
Joni Ramirez Merryman Communications
joni@merrymancommunications.com 323.532.0746
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