Stroke Teams enroll first patient in clinical trial of Penumbra System with Pulse flow restoration device

The Stroke Teams at the University Hospital Dresden in Dresden, Germany, and the University Hospital Göttingen in Göttingen, Germany, have enrolled the first patients in an international clinical trial to assess the safety and effectiveness of aspiration with the Penumbra System^® in conjunction with the Pulse™ flow restoration device. Following on the demonstrated safety and marked effectiveness of the Penumbra System, the PULSE trial aims to demonstrate the performance of an additional adjunctive mode of immediate flow restoration using a temporary stent.

“Our experience with the Penumbra System including the Pulse flow restoration device demonstrates that the rapid recanalization of major cerebral arteries is now feasible and may become the stroke treatment of first choice in combination with IV thrombolytics”

"Our experience with the Penumbra System including the Pulse flow restoration device demonstrates that the rapid recanalization of major cerebral arteries is now feasible and may become the stroke treatment of first choice in combination with IV thrombolytics," said Prof. Dr. Rüdiger von Kummer, Head of the Department of Neuroradiology and Director of the Dresden University Stroke Center in Dresden, Germany.

"A quick and complete reperfusion of brain tissue is important in the acute phase of many strokes in which a major brain artery is blocked. Mechanical devices designed for intra-arterial use may prove to be more effective than IV thrombolysis in achieving that goal," said Prof. Dr. Michael Knauth, Director, Department of Neuroradiology, University of Göttingen.

The Pulse flow restoration device is a self-expanding, fully retrievable, dense mesh temporary stent designed to be deployed into a clot blocking blood flow to the brain. The Pulse flow restoration device is designed to offer immediate flow restoration while simultaneously allowing the continued aspiration of clot using the Penumbra System. It was designed by Penumbra's research and development team, which has over twelve years of industry experience focused on the application of nitinol stent technology for the treatment of neurovascular diseases including aneurysms, intracranial stenosis, and acute stroke.

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 three years and is now used in the majority of patients interventionally treated for acute ischemic stroke.