Stroke is the third leading cause of death and second leading cause of disability in the U.S. The majority of strokes are caused by cerebral infarction due to acute thrombus and arterial occlusion. The fundamental therapeutic goal is to provide rapid removal of the culprit thrombus, which improves cerebral blood flow and rescues ischemic, but not yet dead brain tissue. Early reperfusion is crucial, since irreversible brain injury occurs when the occlusion persists beyond two to three hours. Rheolytic thrombectomy uses high velocity saline jets to create a localized vacuum at the tip of a catheter for percutaneous thrombus removal. The vacuum entrains thrombus into the jets, where it is macerated and evacuated through the same catheter. A unique rheolytic catheter--NV150-- has been designed with adequate diameter, length and flexibility to access the cerebral arteries. Animal studies demonstrated that the NV150 catheter could be delivered to target arterial segments and successfully used for the removal of acute thrombus. Initial clinical results showed that the catheter successfully removed thrombus from the cerebral artery of a stroke patient, resulting in immediate clinical improvement and thus demonstrating the clinical potential for the NV150 catheter. The applicants propose to further investigate the reperfusion feasibility and safety of the NV150 catheter for cerebral artery thrombectomy in patients with ischemic stroke, and to optimize the manufacturing processes to produce a robust catheter design. They anticipate this product development will provide a valuable and cost-effective therapy for the treatment of ischemic stroke. PROPOSED COMMERCIAL APPLICATION: The need for a treatment which provides safe, rapid and effective restoration of blood flow through occluded cerebral arteries in acute stroke patients is immense. Treatment of acute stroke with rheolytic thrombectomy has potential to provide a large unmet clinical need and represents a large future market opportunity. We anticipate that the NV150 rheolytic thrombectomy catheter will provide a valuable and cost-effective therapy for the treatment of acute ischemic stroke.
