Integra LifeSciences has obtained the US Food and Drug Administration (FDA) approval for its Camino Flex ventricular catheter for use with magnetic resonance imaging (MRI).
The Camino Flex ventricular catheter is MR conditional at 1.5 and 3.0 T, with a sensor designed to measure directly at the source. The advanced, tunneled ventricular catheter is designed for use with Integra’s Camino monitor.
Integra LifeSciences’ Camino Flex ventricular catheter, when coupled with Camino Monitor, provides clinicians access to a truly advanced system for the diagnosis and treatment of compromised neurological conditions.
According to Integra LifeSciences, more than 800 centers in the US use the Camino platform for conditions that cause an elevated intracranial pressure (ICP), including traumatic brain injury, subarachnoid hemorrhage, and stroke.
The ventricular catheter continuously monitors ICP independently in the ventricles, even when cerebrospinal fluid (CSF) flow cannot be established or the catheter is occluded by a blood clot.
Multilumen design of the device allows for simultaneous CSF drainage and ICP monitoring, and provides a continuous measurement of ICP and waveforms.
Launched in 2013, the Camino monitor integrates strain gauge and fiber optic monitoring technologies. The monitor is designed to incorporate both tunneled and bolted advanced monitoring technologies, which monitor ICP in either the parenchyma or ventricle space.
The Camino monitor features up to five days of patient ICP data trending, and has a large and highly visible touchscreen interface.
Integra LifeSciences Neurosurgery marketing vice president Peter Ligotti noted the company is very pleased that its Camino Flex ventricular catheter is approved for MRI scans.
"MRI scans for patients receiving neuromonitoring are becoming more prevalent, and patients implanted with Integra’s Camino Flex Ventricular Catheter can now safely undergo MRI scans without the need to remove the catheter.
"This is especially beneficial for neuro patients whose management includes both CSF drainage and follow-up MRI," Ligotti added.