Penumbra Scientific Session News - Penumbra, Inc.

Penumbra Scientific Session News
SNIS 2012
Europe Edition
San Diego, CA
July 2012 | Volume 4
ISCHEMIC
ACCESS
Penumbra System ®
MAX
Simplifies Stroke Procedures
Dr. Sam Zaidat, Director of the Neurointerventional Program at the Medical College of
Wisconsin reported the addition of Penumbra MAX Reperfusion Catheters (3MAX, 4MAX,
and 5MAX) to the Therapy Trial protocol 1 . Dr. Zaidat noted the new, advanced polymer and
Nitinol coil reinforcement design have optimized the trackability of these catheters, allowing
the 4MAX and 3MAX specifically to be
delivered over a 0.014” wire alone. In one of the
cases he presented, a 3MAX easily tracked into a fetal PComm
and quickly removed thrombus that had been embolized earlier
by a commercially available stent retriever. The new MAX line of
Reperfusion Catheters offers the complete range of therapeutic options
to interventionalists on a simplified, fully compatible aspiration platform.
Hemorrhagic
Penumbra Coil 400 have Higher Occlusion Rates
at 6 Months than Conventional Coils
Dr. Aman Patel, Professor, Neurosurgery/Radiology, Mt. Sinai School of Medicine, et. al.
presented a single center, retrospective case review of 111 aneurysms, in the abstract,
Aneurysm Embolization Treatment Efficiency: Comparing the Penumbra Coil 400 System to
Conventional Coils 2 . The PC 400 cases had a greater percentage of Class I Raymond Scale
occlusion (88.9%), despite statistically significant greater aneurysm volume, compared to
controls (61.4%).“Our data confirms that when compared to conventional coils, the PC 400 is
indeed more efficient in the embolization of cerebral aneurysms,” the study concluded.
Penumbra Redefines
Endovascular Access with
New PX 400 Coil Delivery
Microcatheter
In the abstract, Redefining Endovascular
Access for Treatment of Intracranial
Aneurysms, Dr. Thomas Grobelny, Director,
Neurosciences Institute, Advocate Christ
Medical Center, Oak Lawn, IL, noted that
the Penumbra PX 400 microcatheter
had navigation, aneurysm selection and
coil delivery characteristics similar to
conventional microcatheters. 3
He concluded that the advanced
technology and material engineering
used redefines microcatheter size
limits for treatment of aneurysms
and may enable a significant
advancement not
previously possible
with conventional
coil treatment.
PX 400
microcatheter
PC 400
(.020") (n=16)
Conventional Coils
(.010"–.015") (n=95)
Aneurysm Volume 204.3 a 154.5
Mean # Coils Used 3.9 5.5
Mean Procedure Time (min) 46.7 58.8
Mean Packing Density (%) 36.2 b 27.5
Procedural Events 0 0
Raymond Scale-Class I Occlusion at 6
Months Post-procedure (%)
Comparison to Immediate Post-treatment:
Better / Same / Worse (%)
88.9
(n=9)
61.4
(n=44)
66.7 / 33.3 / 0 36.4 / 52.2 / 11.4
Penumbra Coil 400
Complex Extra Soft
Statistically Significant: a P < 0.05 b P < 0.005 (Nonparametric Wilcoxon Ranked Text)

ISCHEMIC
Maximizing Treatment Effect
in the THERAPY Trial
The Interventional Management of Stroke
III (IMSIII) Trial was halted earlier this year
because the trial investigators did not
believe it would show statistically superior
results for stroke intervention over
intravenous drug use alone.
THERAPY, a randomized control study
being conducted by Penumbra,
Inc. continues the mission to study
interventional stroke treatment outcomes
begun by IMSIII. Dr. J Mocco, Associate
Professor of Neurological Surgery,
Radiology, and Radiological Sciences
at the Vanderbilt University Medical
Center, emphasized that the goal of any
randomized control trial design is to
demonstrate a treatment effect between
the control arm and interventional arm 4 .
Clinical evidence from the START Trial
showed that patients selected for
small core infarct volume reported the
best outcomes. However, Dr. Mocco
explained that core infarct volume makes
a poor patient selection criterion for a
randomized control trial because it will
improve outcomes in both the control and
interventional treatment arms and fail to
demonstrate a large treatment effect.
THERAPY applies a strict patient selection
criterion (length of clot burden in mm) to
select patients who will respond poorly
to IV-tPA alone in the control arm but
who will most benefit from a combined
approach using IV-tPA and interventional
clot removal with the Penumbra System
in the investigational arm. If successful,
these patient selection criteria could be
widely applied in the industry and improve
the standard of care for ischemic
stroke patients.
Dr. Johannes Weber from
St. Gallen, Switzerland, Presents
Early Experience with the
Penumbra 3D
Dr. Johannes Weber, Director of Diagnostic
and Interventional Neuroradiology,
University Hospital St. Gallen, St. Gallen,
Switzerland reported his early experience
with Penumbra 3D 5 . Dr. Weber remarked
that the unique intraluminal 3D chambers
make the 3D the next innovation in clot
extraction devices.
In the first fourteen patients treated with
the 3D device at St. Gallen, Dr. Weber
reported 94% revascularization to TICI 2b
or above, with no observed vasospasm
or embolization of new territory (ENT).
He noted the advantages of combining
lesional aspiration with the 3D, which
include reducing the risk of losing
thrombus to a new territory while
providing a multi-modal approach to clot
removal. The 3D device is currently being
investigated in an FDA approved IDE trial
in the US.
START Trial Confirms Favorable
Penumbra SystemOutcomes
with 48% of Patients Living
Independently at 90 Days
A presentation on the interim results of
the START Trial by Dr. Don Frei, Director
of Neurointerventional Surgery, Radiology
Imaging Associates/Swedish Medical
Center in Denver, CO, and a Principal
Investigator of the START Trial, opened
the scientific session on the first day of the
SNIS annual meeting 6 . A panel of reviewers
voted the START Trial as “best science”
of the meeting.
The START Trial, a prospective, multicenter
core-lab adjudicated study, reports
48% (37/77) of patients achieved
mRS ≤ 2 at 90 days after treatment
with the Penumbra System ® . TIMI 2–3
revascularization was achieved in 86% of
patients. When patients were selected by
ASPECTS on CTA source images, the rate
of good outcomes (mRS 0–2 at 90 days)
was 64.3% in the ASPECTS 8–10 group.
Mean age for the START dataset was 66
with a mean NIHSS of 19.4.
Hemorrhagic
High Volume Center Demonstrates
Wide Use of Penumbra Coil 400
In their abstract, Clinical Experience and
Lessons Learned with the Penumbra
PC 400 Large Volume Coil: Improving
the Treatment of Both Large and Small
Aneurysms, Drs. Blaise Baxter and Steven
Quarfordt of Erlanger Medical Center,
Chatanooga, TN, concluded that the
“softness by design of this large volume
coil combined with the improved body of
the deployment catheter has markedly
improved the treatment of both large and
small aneurysms.” 7
“Follow-up data suggest that the use of
the coils produced durable occlusions,”
concluded the investigators.
SOURCES
1. Zaidat O. THERAPY Trial: New Devices Update. Symposium
presentation at: 10th Annual Meeting of the Society of
Neurointerventional Surgery; July 23-26, 2012; San Diego,
CA. USA.
2. Patel A, Kamath A, Ploykarpou M, Mascitelli J, Patel
A, Moyle H. Aneurysm Embolization Treatment Efficiency:
Comparing the Penumbra Coil 400TM System to Conventional
Coils. Paper presented at: 10th Annual Meeting of the
Society of Neurointerventional Surgery; July 23-26, 2012;
San Diego, CA. USA.
3. Grobelny T. Redefining Endovascular Access for Treatment
of Intracranial Aneurysms. Poster presented at: 10th Annual
Meeting of the Society of Neurointerventional Surgery; July
23-26, 2012; San Diego, CA. USA.
4. Mocco J. THERAPY Trial: Design and Rationale—The
Randomized, Concurrent Controlled Trial to Assess the
Penumbra System’s Safety and Effectiveness in the Treatment
of Acute Stroke. Symposium presentation at: 10th
Annual Meeting of the Society of Neurointerventional
Surgery; July 23-26, 2012; San Diego, CA. USA
5. Weber J. Early European Experience with the Penumbra
3D. Symposium presentation at: 10th Annual Meeting of the
Society of Neurointerventional Surgery; July 23-26, 2012;
San Diego, CA. USA
6. Frei D, Yoo A, Heck D, et al. Pre-treatment CTA Aspects
as a Predictor of Clinical Outcome in Endovascular Stroke
Therapy (EVT): Results from the Penumbra START Trial.
Paper presented at: 10th Annual Meeting of the Society of
Neurointerventional Surgery; July 23-26, 2012; San Diego,
CA. USA.
7. Baxter B, Quarfordt S. Clinical Experience and Lessons
Learned with the Penumbra PC 400 Large Volume Coil:
Improving the Treatment of Both Large and Small
Aneurysms. Poster presented at: 10th Annual Meeting of
the Society of Neurointerventional Surgery; July 23-26,
2012; San Diego, CA. USA.
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Copyright ©2012 Penumbra, Inc. All rights reserved. The Penumbra logo, Penumbra System, Penumbra System MAX, Penumbra Coil 400 and Penumbra 3D are registered trademarks
or trademarks of Penumbra, Inc. in the USA and other countries. All other brands and product names are registered trademarks or trademarks of their respective owners. CO LI 5654, Rev. A 08/12 OUS