Branchpoint Technologies(TM) announces FDA 510(k) for its AURA(TM) Intracranial Pressure Monitoring System
Branchpoint Technologies(TM) announces FDA 510(k) for its AURA(TM) Intracranial Pressure Monitoring System
System includes a fully implantable and wireless intracranial pressure (ICP) sensor
IRVINE, Calif., May 31, 2018 /PRNewswire/ -- Branchpoint Technologies, a company dedicated to providing accurate, reliable and cost-effective mobile solutions for intracranial pressure (ICP) monitoring, announced that the United States Food and Drug Administration (FDA) has granted 510(k) clearance for its AURA(TM) ICP Monitoring System. The AURA(TM) ICP Monitoring System includes a fully implantable and wireless intracranial pressure (ICP) sensor that, for the first time ever, enables truly mobile ICP monitoring in brain-injured patients. Unlike traditional ICP monitoring systems requiring a cabled connection with the patient's brain, the AURA(TM) system is completely wireless in both power and transmission of patient data directly to a bedside monitor. AURA(TM) enables continuous telemetric monitoring of parenchymal ICP including continuous ICP waveforms and eliminates the need for additional capital equipment investments.
"The AURA(TM) ICP monitoring system is a ground breaking and long-sought advancement that enables ICP monitoring without the need for a tethered connection between the patient's brain and the bedside monitor," said Dr. Michael Muhonen, Director of Neurosurgery and Medical Director of the Neuroscience Institute at Children's Hospital of Orange County (CHOC). "With traditional ICP monitoring systems, patient mobility within the hospital is cumbersome and product dislodgement and malfunction is common. AURA(TM) solves these problems, facilitates better ICP vigilance throughout the hospital and will benefit our patients immediately. Longer term, I am equally excited by the potential of the AURA(TM) platform in combination with a shunt for better hydrocephalus management."
William Worthen, Executive Chairman at Branchpoint Technologies, said, "Innovation in the ICP monitoring space has been lacking and long overdue and this is a significant milestone for Branchpoint and for patients whom require intracranial pressure monitoring. Branchpoint has done an amazing job conceiving, developing and bringing about FDA clearance for this disruptive technology. We are planning immediate commercial cases to gain early customer feedback while we explore strategic options for the technology."
About Branchpoint Technologies(TM)
Branchpoint Technologies is a private company located in Irvine, California, that develops and manufactures reliable, accurate and cost-effective mobile solutions for intracranial pressure monitoring in patients with brain injury.
About Intracranial Pressure (ICP) Monitoring
Elevated intracranial pressure (ICP) is seen in head trauma, hydrocephalus, intracranial hemorrhage, sub-arachnoid hemorrhage from ruptured brain aneurysm, intracranial tumors, hepatic encephalopathy, and cerebral edema. Intractable elevated ICP can lead to death or devastating neurological damage either by reducing cerebral perfusion pressure (CPP) and causing cerebral ischemia or by compressing and causing herniation of the brainstem or other vital structures. Prompt recognition is crucial in order to intervene appropriately.
Intractable high ICP is the most common "terminal event" leading to death in neurosurgical patients. The association between the severity of intracranial hypertension and poor outcome after severe head injury is well recognized.( ) Outcomes tend to be good in patients with normal ICP, whereas those with elevated ICP are much more likely to have an unfavorable outcome.( ) Elevated ICP carries a mortality rate of around 20%.
The rapid recognition of elevated ICP is therefore of obvious and paramount importance so that it can be monitored and so that therapies directed at lowering ICP can be initiated. A raised ICP is measurable both clinically and quantitatively. Continuous ICP monitoring is important both for assessing the efficacy of therapeutic measures and for evaluating the evolution of brain injury.
https://emedicine.medscape.com/article/1829950-overview
Media Contact:
Nicholas Hu
Chief Operating Officer
Branchpoint Technologies
corporate@branchpt.com
949-829-1868
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SOURCE Branchpoint Technologies
