October 8, 2019
First Stroke Patients Treated With Insera's Clear Cyclical Aspiration System
October 8, 2019—Insera Therapeutics, Inc. announced that the first two ischemic stroke patients have been treated with the company’s Clear cyclical aspiration system. The procedures were performed by Vladimir Kalousek, MD, an interventional neuroradiologist at the Sisters of Charity Hospital in Zagreb, Croatia. The company received European CE Mark approval for the Clear device in March 2019.
According to the company, the Clear aspiration system is a digital vacuum aspiration system that allows operators to employ uniform suction or cyclical suction patterns. The pump can be optionally operated via an iPad app, which also collects system-of-care chronology (such as time metrics in the stroke chain of survival) and key angiosuite metrics (such as expanded treatment in cerebral infarction [eTICI] outcomes).
Dr. Kalousek commented in the company’s announcement, “We used the Clear aspiration system to remove blood clots from two stroke patients, one from the anterior circulation and the other from the posterior circulation. I am extremely pleased with the device and believe the cyclical nature of the aspiration offers unique safety and efficacy advantages over existing devices.”
He continued, “Cyclical aspiration was used as primary therapy for the first patient, resulting in first-pass eTICI 3 outcome (complete vessel reopening) within 6 minutes. The first patient had a blood clot resulting in a large vessel occlusion in the M1 segment of the middle cerebral artery and had a witnessed stroke onset in the early time window. The second patient had a blood clot in the posterior circulation in the basilar artery with extremely tortuous vessels and had an unknown time of stroke onset as she woke up with stroke symptoms. Cyclical aspiration was used successfully in conjunction with stent retriever technology for removing the entirety of the clot.”