REDMOND, Wash., Dec. 19, 2011 /PRNewswire/ -- Cerevast Therapeutics Inc., a privately held medical technology company, announced today that it has received CE mark clearance of its SonoLysis Headframe System, the Clotbust ER™providing approval to commercialize the product in Europe.
The Clotbust ER™ is a first-in-class ultrasound device for the treatment of ischemic stroke, representing a novel product in an extremely high area of unmet medical need. Designed for rapid deployment in the emergency room setting, the device has been engineered to non-invasively deliver therapeutic ultrasound energy to the region of the occluded vessel in the brain as a treatment for ischemic stroke when used in combination with standard intravenous thrombolytic therapy (tissue plasminogen activator - tPA/Alteplase).
The device contains multiple transducers incorporated into a unique, operator-independent headframe. The Clotbust ER™ is designed to self-align the transducers based on common landmarks on the skull. Proprietary software controls the ultrasound parameters, which in turn allows the device to deliver consistent therapeutic levels of ultrasound energy necessary to achieve acoustic streaming and enhanced clot lysis within the occluded vessel of the brain without the need for a trained sonographer or vascular technician.
"Achieving CE mark clearance represents a major accomplishment for Cerevast," said Bradford A. Zakes, Chief Executive Officer. "The Clotbust ER™ significantly reduces the technical challenges associated with the administration of transcranial ultrasound for the treatment of ischemic stroke. Unlike conventional Doppler instruments that are designed and approved for diagnostic purposes only, the Clot