VAL DISERE, France–(BUSINESS
WIRE)–At last weeks ABC-WIN Seminar, Prof. Dr. Michael Knauth, Director
of Neuroradiology, University Hospital of Goettingen, Goettingen, Germany, and
President-elect of the German Society of Neuroradiology, presented the European
evaluation data on Separator 3D, a next-generation clot engagement device that
works in conjunction with aspiration at the site of the lesion causing an acute
ischemic stroke to remove the clot and restore blood flow to affected brain
“Our evaluation cases at six European centers, the first
cases in the world performed with this new device, show an approximately 90%
recanalization success. The device also demonstrated that it was easy to
navigate and deliver to the site of occlusion, even in very tortuous anatomy.
The geometry of this new device may prove to better secure the full length of
the clot while aspiration removes the clot from the patients affected vessel.
Further experience and follow-up is required to confirm preliminary, promising
results,” remarked Dr. Knauth.
“We have performed quite a few cases at our center with the
new Penumbra 3D device,” said Prof. Dr. Olav Jansen, Director of the Institute of Neuroradiology,
University Hospital Kiel, Kiel,
President of the German Society of Neuroradiology. “I was impressed in
particular with the smoothness of delivery and resheathing of the device into
the microcatheter. We have had success in a wide variety of anatomical
situations already, including long clots, focal clots, and clots at difficult
bifurcations. The 3D is really a substantial advancement in the technology we
have available to us to treat this difficult condition.”
“The new Penumbra 3D device differs in some key aspects from
other thrombectomy systems,” said PD Dr. med. Werner Weber, Head of the
Department of Radiology and Interventional Neuroradiology, Klinikum Vest,
Knappschaftskrankenhaus, Recklinghausen, Germany. “Because of its 3-dimensional
characteristics, it has a different geometry than other companies devices. The
3D Separator also has extremely good pushability, especially through distal,
more tortuous segments due to the stability of the distal pusher wire. The
combination of the 3D Separator together with aspiration allows for removal of
clots, due to their consistency, which could not otherwise be removed with stent
retrievers alone. We have seen several cases in which lesional aspiration
together with the 3D Separator has been key to the success of the proceedure.
For example, using the 054 Reperfusion Catheter just in front of the site of
the occlusion enables good results.”
“I think the 3D really is a quantum
leap over the other devices and the most
innovative clot extraction device. Compatibility is good
with other Penumbra catheters such as the Reperfusion Catheter
054. The radiopaque markers are also extremely helpful,
and the device is easy to handle, tracking nicely through
tortuosity. It seems as if the Penumbra 3D
defines a new category of stroke devices,” said Dr.
med. Johannes Weber, Director of Diagnostic and Interventional
Neuroradiology, University Hospital St. Gallen, St. Gallen Switzerland.
The Penumbra System Separator 3D has CE Mark and is now
widely available in CE countries. It is under clinical trial in the United States.
ABOUT the Penumbra System and Separator 3D
The Separator 3D is a next generation clot-securing device,
which aids aspiration thrombectomy through the Penumbra System family of
The Penumbra System continuous aspiration thrombectomy
devices are used by neuro-interventional specialists to gently remove clots
from the large vessels of the brain that are causing an acute stroke. The
Penumbra System has been commercially available worldwide for over four years
and is now used in the majority of all interventionally treated patients with
acute ischemic stroke.
Penumbra, Inc. (www.penumbrainc.com) is an independent medical device
company committed to delivering clinically beneficial products that help
patients suffering from stroke and other neurovascular diseases. Penumbras
global headquarters is located in Alameda, California with sales operations in North and South
America, Europe, Australia
Posted by Sean Fenske, Editor-in-Chief, MDT