New Surgical Tool Released to Treat Deep Brain Bleeding

Penumbra Inc. has launched the Apollo System, a new surgical tool that enables minimally invasive removal of deeply seated tissue and fluids in the brain during a single 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.

The first patient treated with the device was a 41-year-old man who suffered spontaneous bleeding deep in his brain that shifted his ventricuar system, interrupted fluid circulation and compressed his midbrain. Despite standard measures including a ventricular catheter to drain fluid, doctors could not control the overall pressure in his brain. Particularly concerning to clinicians was the patient’s comatose appearance — a fixed downward gaze consistent with a Parinaud’s Syndrome; such a gaze is a warning of potential irreversible brain damage.

“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,” said ” Alexander Khalessi, M.D., assistant professor of Surgery and Neurosciences at UC San Diego Medical Center (California) and Surgical Director of Neurocritical Care, who treated the first patient. “For my patient, I was concerned his need was more urgent, and 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.”

That initial success led doctors to use the Apollo device in a second, 51-year-old patient with a massive hemorrhage. Apollo facilitated complete removal through a small incision in the eyebrow, according to Khalessi. The patient left the intensive care unit within 24 hours and like the first, went from a near fatal situation in the hospital to recovering in a rehabilitation facility.

David Fiorella, M.D., professor of Clinical Neurological Surgery and Radiology at Stony Brook University Medical Center (New York), compared the Apollo to alternative techniques, noting patients with hemorrhagic stroke have poor outcomes and long hospital stays. Those treated with the Apollo device show improvement within hours, he claims, and continue to improve during their hospitalization.  

“While we were surprised by our patients’ 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,” Fiorella said. “In addition, with the MISTIE technique, clot reduction required several days of drainage through a small catheter left in place after surgery. With the Apollo System, we may be able to achieve the desired level of clot reduction immediately and safely in most patients. While these early results 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.”

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. 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.

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.

Privately held Penumbra is based in Alameda, Calif.