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TMCNet:  A Pioneering New Surgical Tool Provides Hope for Patients with Inoperable Deep Bleeding in the Brain

[July 03, 2014]

A Pioneering New Surgical Tool Provides Hope for Patients with Inoperable Deep Bleeding in the Brain

ALAMEDA, Calif. --(Business Wire)--

The Apollo™ System, manufactured by California-based Penumbra, Inc., was widely launched today following first-in-man clinical use at leading US hospitals.

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 rehabilitation facility.


"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.

ABOUT Penumbra

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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