NeVa Systems - Embolectomy/thrombectomy suction catheter

Intended purpose

The Vesalio NeVa Mechanical Thrombectomy System is indicated for temporary use to restore blood flow in the cerebral vasculature of patients suffering from an acute ischemic stroke within the first 8 hours of symptoms onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. The Vesalio NeVa Mechanical Thrombectomy System is positioned across the embolus or blood clot and is used to facilitate the restoration of blood flow and removal of the clot obstruction. The Vesalio NeVa Mechanical Thrombectomy System is indicated for: • Endovascular temporary use in patients with acute ischemic stroke • Endovascular temporary use to restore blood flow in patients who are experiencing symptoms of an acute ischemic stroke caused by an embolus in a cerebral vessel

Functional description

The Vesalio NeVa Mechanical Thrombectomy System is delivered to and positioned across the embolus and unsheathed creating channels within the clot for blood to flow. Should blood flow stop, the device can be recaptured and redeployed. If the clot does not resolve after three (3) successive captures and device deployments then the device and clot can be slowly withdrawn from the vessel into the guide catheter while aspirating with a syringe.