- Latest STRIKE-PE data show that computer assisted vacuum
thrombectomy (CAVT) for the treatment of pulmonary embolism is safe
and effective at reducing right heart strain; it also improved
clinical and functional outcomes
- Penumbra's Indigo® Aspiration with
Lightning™ portfolio offers the only CAVT technologies
currently available in the U.S.
ALAMEDA,
Calif., Nov. 1, 2023 /PRNewswire/ -- Penumbra,
Inc. (NYSE: PEN), a global healthcare company focused on innovative
therapies, announced the latest STRIKE-PE data evaluating
Penumbra's Indigo® Aspiration System with Lightning™. The results
show Penumbra's computer assisted vacuum thrombectomy (CAVT) is
safe and effective at reducing right heart strain. It also improved
clinical outcomes, including heart rate and respiratory rate, and
functional outcomes, including dyspnea, walking distance and New
York Heart Association (NYHA) classification, when used to treat
acute high and intermediate risk pulmonary embolism (PE). The data
were presented at this week's Vascular Interventional Advances
(VIVA) 2023 Conference.
"The latest STRIKE-PE data looking at the first 150 patients
show that not only is Penumbra's Indigo System safe and effective
for removing thrombus, but also confirm that the removal of the
clot can have a significant, positive physiologic impact on
patients," said James F. Benenati,
M.D., FSIR, chief medical officer at Penumbra. "The latest
STRIKE-PE data add to the growing body of evidence that
demonstrates the significant benefits of CAVT, which is redefining
the way physicians treat significant symptomatic pulmonary
emboli."
Penumbra's CAVT is designed to allow physicians to remove large
blood clots in the body safely, simply and with speed. The interim
results of the prospective, muti-center study, which evaluated
Penumbra's Lightning technology in 150 of 600 anticipated patients
to be enrolled, include:
Safety & Performance:
- Low 48hr major adverse event rate of 2.7%
- Low 48hr major bleeding rate of 2.7%
- Significant reduction of right ventricle/left ventricle ratio
by 25.7%
Functional Measures:
- Significantly improved patient reported shortness of breath
(dyspnea) by discharge with increasing improvement by 90-days
- Functional ability, measured by 6-minute walk distance,
significantly increased by 120 meters from discharge to
90-days
- Patients returned to pre-PE state with no significant
difference in NYHA classification from before the event to
90-days
"The complexity of treating pulmonary embolisms appropriately
cannot be overstated. They are often complicated to diagnose and,
in many cases, if not treated quickly, can be life-threatening,"
said Ido Weinberg, M.D., who presented the data and is a vascular
medicine physician at the Massachusetts General Hospital. "While
surviving a pulmonary embolism is a victory, patients regaining
their quality of life and ability to function without ongoing
limitation is critical. The STRIKE-PE data set is very encouraging
as it confirms the promise of CAVT to restore blood flow quickly,
safely and effectively while also showing promising, prompt and
lasting improvement in patient outcomes."
Additional STRIKE-PE data were previously presented at the
recent TCT Annual Scientific Meeting, showing improved
quality-of-life outcomes, including improved mobility and ability
to provide self-care and a decrease in pain/discomfort from
discharge to 90-day follow-up.
"The real-world data from STRIKE-PE allow us, for the first
time, to continuously evaluate the impact of intermediate and
high-risk PE treated with CAVT," said John
Moriarty, M.D., principal investigator of the STRIKE-PE
study and interventional radiologist at University of California, Los Angeles. "The latest
results continue to show improved functional outcomes and quality
of life, suggesting that CAVT should be considered as a valuable
frontline treatment option."
In the U.S., an estimated 900,000 cases of symptomatic PE occur
annually[i]. Incomplete physical recovery after PE has been
documented as a common outcome as patients often report decreased
quality of life and persistent shortness of breath. Pulmonary
embolism can be life-threatening with 10-30 percent of individuals
dying within one month of diagnosisi.
"We believe that our CAVT technology will help transform care so
PE patients can return home quickly with minimal impairments and
minimal impact on their quality of life," said Adam Elsesser, president and chief executive
officer of Penumbra, Inc. "The latest STRIKE-PE data confirm that
the safety, speed and simplicity of our devices can have a lasting
impact on patients and our focus on clinical evidence will continue
to advance the patient care paradigm."
Penumbra is also conducting STORM-PE, a first-of-its kind
randomized controlled trial comparing CAVT using Penumbra's
Lightning Flash with anticoagulation versus anticoagulation alone,
with the goal of showing the clinical benefits to patients who
receive CAVT.
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 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 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:
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 (SEC), including our Annual
Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on
February 23, 2023. 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
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jheth@penumbrainc.com
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parinaz@merrymancommunications.com
|
510-995-9791
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310.600.6746
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i "Learn about Pulmonary Embolism,"American Lung
Association. Accessed on Oct. 26,
2023.
https://www.lung.org/lung-health-diseases/lung-disease-lookup/pulmonary-embolism/learn-about-pulmonary-embolism
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SOURCE Penumbra, Inc.