Randomized Penumbra 3D Trial of Next Generation Stent Retriever Meets Primary Endpoints
July 27 2016 - 12:24PM
Business Wire
Data Also Highlight Frontline Effectiveness of
Aspiration Using Penumbra System® for Stroke
Revascularization
Penumbra, Inc. (NYSE: PEN), a global interventional therapies
company, today announced that the Penumbra 3D Trial successfully
met the primary trial endpoints, demonstrating non-inferiority in
both safety and efficacy of the company’s next-generation stent
retriever, Penumbra 3D Revascularization Device, when used with
Penumbra System aspiration devices compared to Penumbra System
aspiration devices alone. The data were presented in the Late
Breaking Abstract Presentations session today at the Society of
NeuroInterventional Surgery (SNIS) 13th Annual Meeting in Boston,
Massachusetts.
Results showed non-inferior revascularization rates according to
the FDA-defined primary effectiveness measure of TICI 2-3 in the
Penumbra 3D Revascularization Device with Penumbra System
aspiration devices arm (3D+aspiration device arm) compared to the
Penumbra System aspiration devices only arm (aspiration device-only
arm) (88.5 percent vs. 85.9 percent). In addition, the more
strictly defined revascularization measure, TICI 2b/3, showed
non-inferiority between the 3D+aspiration device arm and the
aspiration device-only arm (83.9 percent vs 74.1 percent). The
primary safety endpoints – device-related serious adverse events
(SAEs) and procedure-related SAEs – were not statistically
different between the two arms (p=1.0 and p=0.4920,
respectively).
“The results of the Penumbra 3D Trial speak positively on the
use of Penumbra’s 3D Revascularization Device in combination with
the Penumbra System aspiration devices, as well as on the use of
Penumbra System aspiration devices alone,” said Donald Frei,
MD, lead investigator of the study and director,
NeuroInterventional Surgery at Radiology Imaging Associates/Swedish
Medical Center in Englewood, Colorado. “The data also suggest that
the revascularization rate in the Penumbra 3D plus aspiration
device arm and the aspiration device-only arm – 83.9 and 74.1
percent, respectively – compare favorably to the 71 percent
revascularization rate published in the HERMES meta-analysis of
five major randomized controlled trials in acute ischemic
stroke.”
Patients in both arms experienced similar rates of return to
functional independence (mRS ≤ 2 at 90 days): 41.6 percent in the
3D+aspiration device arm and 48.8 percent in the aspiration
device-only arm (p=0.4260). These clinical outcomes were obtained
without the benefit of selecting patients using imaging techniques
designed to detect viable brain tissue.
“The trial results are encouraging for our Penumbra 3D
Revascularization Device, and we are focused on continuing our plan
to pursue regulatory submission by the end of this year,” said Adam
Elsesser, chairman and chief executive officer of Penumbra.
“Furthermore, the broader implications of the data support
frontline use of the Penumbra System direct aspiration devices in
the revascularization of stroke patients.”
About the Penumbra 3D Trial
The Penumbra 3D Trial was a prospective, randomized controlled
non-inferiority study that compared the safety and efficacy of the
Penumbra 3D Revascularization Device, used in conjunction with
Penumbra System aspiration devices, to that of Penumbra System
aspiration devices alone for the endovascular treatment of acute
ischemic stroke patients with a large vessel occlusion. The primary
study endpoints included core lab-adjudicated angiographic
revascularization and safety. A total of 198 patients were
randomized at 25 U.S. centers. The Penumbra 3D Revascularization
Device is approved for investigational use only in the United
States.
About the Penumbra System
The Penumbra System consists of large diameter, highly flexible,
and reliably trackable reperfusion catheters that utilize the full
aspiration power of the Penumbra Pump MAX™ through its Hi-Flow
Aspiration Tubing. This integrated, proprietary system removes
stroke-causing occlusions safely and effectively. The next
generation Penumbra 3D Revascularization Device is designed to be
used with the Penumbra System’s family of reperfusion catheters. It
features innovative three-dimensional chambers within the lumen to
enable secure clot engagement while minimizing contact with the
vessel wall. The majority of Penumbra System aspiration devices
used in the 3D Trial included 4MAX™, 5MAX™ and 5MAXACE™ reperfusion
catheters and separators.
About Penumbra
Penumbra, Inc., headquartered in Alameda, California, is a
global interventional therapies company that designs, develops,
manufactures and markets innovative medical devices. The company
has a broad portfolio of products that address challenging medical
conditions and significant clinical needs across two major markets,
neuro and peripheral vascular. Penumbra sells its products to
hospitals primarily through its direct sales organization in the
U.S., most of Europe, Canada and Australia, and through
distributors in select international markets. Penumbra and the
Penumbra logo are trademarks of Penumbra, Inc.
Forward-Looking Statements
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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
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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; and potential adverse
regulatory actions. These risks and uncertainties, as well as
others, are discussed in greater detail in our filings with the
Securities and Exchange Commission, including our Quarterly Reports
on Form 10-Q and our Annual Report on Form 10-K for the year ended
December 31, 2015. 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,
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order to reflect events or circumstances that may change.
Source: Penumbra, Inc.
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Merryman CommunicationsBetsy Merryman,
310-560-8176betsy@merrymancommunications.com
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