Cerevast Therapeutics' Clotbust ER, a sonoLysis headframe system used to treat ischaemic stroke in emergency room settings, has received CE mark approval.
The device is a first-in-class ultrasound device that has been designed to non-invasively deliver therapeutic ultrasound energy to occluded blood vessels in the brain, in conjugation with standard intravenous thrombolytic therapy.
The device contains multiple transducers incorporated into a unique, operator-independent headframe, and will self-align the transducers based on common landmarks on the skull.
The proprietary software controls the ultrasound parameters, which in turn allows the device to deliver consistent therapeutic levels of ultrasound energy required to attain acoustic streaming and improved clot lysis within the occluded vessel of the brain.
Cerevast Therapeutics CEO Bradford Zakes said the Clotbust device considerably reduces the technical challenges associated with the administration of transcranial ultrasound for the treatment of ischaemic stroke.
''Unlike conventional Doppler instruments that are designed and approved for diagnostic purposes only, the Clotbust ER delivers therapeutic ultrasound energy to the region of the occlusion without the need to aim the transducer or hold it in place by hand for extended periods of time,'' Zakes said.
''This represents a major advancement in the emergency room setting where trained sonographers or vascular technicians are not always available."
UAB Comprehensive Stroke Research Center director Andrei Alexandrov said the operator-independent design of the Clotbust ER provides safe, fast and reliable amplification of systemic thrombolytic treatment in the emergency room setting.
''I look forward to the benefit this product will bring to those patients that suffer the debilitating effects of an ischemic stroke," Alexandrov said.
An earlier Phase I/II trial demonstrated that 15 healthy volunteers were safely treated with two hours of continuous ultrasound insonation using the device.