The Apollo™ System, manufactured by California-based Penumbra, Inc., was
widely launched today following first-in-man clinical use at leading US
Apollo is an innovative new surgical tool that enables minimally
invasive removal of deeply seated tissue and fluids in the brain during
a single, efficient operation. With combined use of an endoscope and
image guidance, the Apollo System allows decompression and removal of
otherwise inoperable blood clots deep in the brain, among other uses.
Dr. Alexander Khalessi, Assistant Professor of Surgery and Neurosciences
at UC San Diego Medical Center and Surgical Director of Neurocritical
Care, successfully treated the first patient in the world using the
Apollo device. Dr. Khalessi explains: "Our first patient was a
41-year-old male who suffered a spontaneous bleeding deep in his brain
that completely shifted his ventricular system, interrupted fluid
circulation and compressed his midbrain. Despite standard measures
including a ventricular catheter to drain fluid, the overall pressure in
his brain was not well controlled. Of greater urgency, the patient was
essentially comatose with a fixed downward gaze consistent with a
Parinaud's Syndrome. With evidence of midbrain compression and this
clinical sign, we knew this gentleman was at risk for time-sensitive,
irreversible damage to the connection between his brain and body.
"Large, decompressive open surgeries for this condition are not
supported in the published data. Ongoing research efforts include a
trial exploring minimally invasive approaches that involve the
implantation of a small catheter with gradual removal of the clot over
many days. For my patient, I was concerned his need was more urgent, and
that the Apollo System would facilitate the same surgical result in
minutes, rather than days.
"Following successful clot removal with the Apollo System, our patient's
gaze improved and we were able to remove brain pressure monitors and
breathing support within 48 hours. As opposed to facing several weeks
comatose in the intensive care unit, our patient was transferred to the
hospital floor, was able to talk to his family, and has since
transitioned to a rehabilitation facility.
"This initial success led to our se of Apollo in a second, 51-year-old
patient with a massive hemorrhage; Apollo facilitated complete removal
through a small incision in the eyebrow. He left the intensive care unit
within 24 hours and like our first patient, went from a near fatal
situation in the hospital, to quickly beginning his recovery in a
"I remain hopeful we are finally making progress in an all too common
and horribly disabling and fatal disease," Dr. Khalessi concluded.
Demetrius Lopes, MD, Section Chief of Cerebrovascular Neurosurgery at
Rush University Medical Center in Chicago, is also an early user. "I
think the arrival of the Apollo System is very timely. We have had great
initial experience in removing intraventricular blood. Use of the Apollo
System has resulted in faster patient recovery and a shortened stay in
the intensive care unit," explained Dr. Lopes.
David Fiorella, MD, Professor of Clinical Neurological Surgery and
Radiology at Stony Brook University Medical Center, discussed his view
on the value of the Apollo System and compared it to alternative
techniques. "Our team at Stony Brook has had tremendous success thus far
using the Apollo System, in conjunction with neuroendoscopy and image
guidance, for the removal of hemorrhages in the brain. This technique
has the potential to be a truly important advance for our field, since
no other treatment has convincingly been shown to help patients with
this lethal disease. Usually patients with this type of hemorrhagic
stroke have very poor outcomes and extremely long hospital stays. Just
hours after treatment, our patients began showing improvement, and they
continued to improve rapidly during their hospital stays.
"While we were very pleasantly surprised by our patients' impressive
clinical responses, some data indicates that these types of outcomes
might be expected. The investigators in the Minimally Invasive Surgery
and tPA in ICH Evacuation (MISTIE II) trial found that when they
achieved near complete removal of blood clots (to less than 10
milliliters remaining), they observed higher rates of good clinical
outcomes. However, this degree of clot reduction was not achieved in
most patients. In addition, with the MISTIE technique, clot reduction
required several days of drainage through a small catheter left in place
after surgery. With the new Apollo System, it seems that we may be able
to achieve the desired level of clot reduction immediately and safely in
most patients. Therefore, it is possible that we will continue to
observe clinical benefits that surpass our former expectations.
"While these early results are certainly impressive and give us
enthusiasm going forward, it is important to recognize that we are very
early on in our experience with this procedure. Much more data will be
required before we know exactly how effective it is and which patients
will benefit most," Dr. Fiorella commented.
The Apollo System is the result of decades of research and development
work in the field of advanced aspiration and vibrational energy
technology by researchers at Penumbra. Advanced aspiration technology
was first developed and perfected in the field of acute ischemic stroke
where blood clots inside the arteries of the brain are starving brain
tissue of vital oxygen and nutrients. The Apollo System adds internal
energy generation to a specialized advanced aspiration tool to
surgically address deep bleeding in the brain, a particularly
devastating form of acute hemorrhagic stroke.
ABOUT The Apollo™ System
The Apollo System combines vacuum, irrigation, and a proprietary
internal vibrational energy to ensure rapid fluid and tissue removal
during minimally invasive neurosurgery through the smallest possible
channel without clogging. The Apollo System is used for the controlled
aspiration of tissue and/or fluid during surgery of the Ventricular
System. The Apollo disposable wand is inserted through the working
channel of a neuroendoscopic trocar.
Penumbra, Inc. (www.penumbrainc.com)
is a medical device company with global headquarters located in Alameda,
California, and sales operations around the world.
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