Early Feasibility Clinical Study of the VitalFlow Stimulator, an Emergency Treatment for Ischemic Stroke

Stroke is the world’s greatest healthcare burden for which few treatment options are available. The long-term objective of the applicant, Nervive, Inc., is to bring to market a non-invasive medical device, the VitalFlow stimulator, as an emergency treatment for ischemic stroke. The VitalFlow is a novel technology that activates the autonomic components of the facial nerve using pulsed magnetic energy, thereby dilating the arteries of the brain and increasing cerebral blood flow (CBF). Delivery of intravenous tissue plasminogen activator (rtPA) to the site of an obstructing blood clot will be improved by increasing CBF, and endovascular clot retrieval catheter navigation will be facilitated by dilation of the cerebral arteries. Thus, the VitalFlow stimulator is highly relevant to the mission of the NINDS because it seeks to improve clinical outcomes in stroke patients and reduce the burden of stroke. With CREATE Devices grant support, we intend to test a clinical prototype VitalFlow stimulator that can be used in the emergency department for the treatment of acute ischemic stroke. The following Specific Aims are proposed: In Phase I of the CREATE Devices project, Nervive will achieve the following:Specific Aim 1: Write the Early Feasibility Clinical Study protocol.Specific Aim 2: Establish a Quality Control System and freeze VitalFlow device design.Specific Aim 3: Complete a Pre-IDE meeting with FDA. In Phase II of the CREATE Devices project, Nervive will achieve the following:Specific Aim 4: Complete external performance testing of the VitalFlow stimulator.Specific Aim 5: Receive FDA IDE clearance and hospital IRB approval.Specific Aim 6: Conduct an Early Feasibility Clinical Study in 8 acute ischemic stroke patients. Nervive is pursuing Expedited Access Pre-Market Approval (PMA) regulatory clearance for the VitalFlow. In the U.S. alone, the commercial opportunity for the VitalFlow includes the sale of device hardware to 5700 hospitals and the sale of consumable components for more than 400k patient treatments each year.Our device, the VitalFlow stimulator, will increase blood flow to the brain during ischemic stroke, thereby preventing injury to the brain that leads to life-long disability. We now propose to test the VitalFlow device as an emergency treatment for ischemic stroke in the emergency department setting in a small group of patients. As a safe, effective, and simple-to-use emergency treatment for ischemic stroke, the VitalFlow stimulator will have an important impact on patient outcomes and long-term disability.