- Lightning Bolt™ 7 is the most advanced arterial thrombectomy
system on the market
- Latest technology combines modulated aspiration with superior
catheter design to maximize blood clot removal in a single
session
ALAMEDA,
Calif., June 1, 2023 /PRNewswire/ -- Penumbra,
Inc. (NYSE: PEN), a global healthcare company focused on innovative
therapies, announced the U.S. Food and Drug Administration (FDA)
clearance and launch of Lightning Bolt™ 7, the most
advanced and powerful arterial thrombectomy system on the market.
Lightning Bolt 7 introduces a new method for removing blood clots,
modulated aspiration, which pairs Penumbra's Lightning Intelligent
Aspiration technology with an advanced microprocessor algorithm.
When used together, Lightning Bolt 7 is designed to enhance the
ability to rapidly remove large, fibrous blood clots in the
arteries with minimal blood loss, addressing conditions such as
acute limb ischemia (ALI), hibernating thrombus and visceral
occlusions.
"The unique mechanism of Lightning Bolt 7 provides modulated
aspiration at the tip of the catheter, enabling the quick removal
of these rigid and stiff blood clots, which oftentimes require open
surgery and frequently result in amputation," said Kalyan Veerina, M.D., interventional
cardiologist at Cardiovascular Institute of the South (CIS).
"Advancements like Lightning Bolt 7 provide a critical frontline
option for physicians to treat patients and improve patient
outcomes."
Powered by the Penumbra ENGINE®, Lightning Bolt 7 is
engineered to detect the difference between blood clot and blood
flow. Additionally, it is designed to identify friction within the
catheter and orchestrate the rapid opening and closing of the
valves to disrupt any resistance between the clot and the catheter
tip. This facilitates maximum vacuum force at the catheter tip for
optimal, rapid ingestion of blood clots. Lightning Bolt 7 is
compatible with Penumbra's arterial catheters, which are made with
MaxID hypotube technology, allowing a larger inner diameter while
maintaining a lower profile and a soft, atraumatic tip design to
maximize the circumferential sweep in the artery.
"This era of computer-aided technology offers the promise of
unheralded procedural efficiency that was not previously available
to endovascular specialists," said Sahil A.
Parikh, M.D., Director of Endovascular Services at
Columbia University Irving Medical
Center. "Our ability to rapidly revascularize vessels with minimal
blood loss is exceptional with these intelligent devices."
"Technologically, Lightning Bolt 7 is a big leap forward," said
Raghu Motaganahalli, MD, FRCS, FACS,
DFSVS, vascular surgeon with Indiana
University Health Physicians. "The computer-aided components
offer a safety profile that, when combined with the clot removal
speed and efficiency, will promote an endovascular-first approach
for a broader range of cases before considering open surgery."
Lightning Bolt 7 received FDA clearance and became available in
March 2023. It is part of Penumbra's
Indigo® System with Lightning portfolio, which are the only
computer-aided mechanical thrombectomy systems currently available
in the U.S. Prior to the availability of Lightning Bolt 7, data
with the Indigo System have shown excellent 30-day limb salvage
rates in more than 98% of patients, short procedure times with an
average of 22 minutes and low 30-day mortality at
3%.1
"With our latest advancements in computer-aided technologies,
Penumbra offers one of the most comprehensive mechanical
thrombectomy product lines for arterial, venous, pulmonary and
mesenteric thrombus," said James F.
Benenati, M.D., FSIR, chief medical officer at Penumbra.
"Lightning Flash and Lightning Bolt 7 will continue to advance the
standard of care for these difficult conditions, removing clot from
the body quickly, safely, in a single session, and without the need
for lytics or open surgery, potentially improving quality of life
for our patients."
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
|
jheth@penumbrainc.com
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parinaz@merrymancommunications.com
|
510-995-9791
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310.600.6746
|
1 Lyden, S et al. A Study of Patients With Lower
Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo
Aspiration System (STRIDE). Presented at: CX 2023, the Charing
Cross International Symposium April
25-27; London, United
Kingdom.
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SOURCE Penumbra, Inc.