FDA Clears Integra’s Camino Flex Ventricular Cather for MRI Use

Plainsboro, N.J.-based Integra LifeSciences Holdings Corporation has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Camino Flex ventricular catheter for use with magnetic resonance imaging (MRI). The catheter is a tunneled ventricular catheter that is MR conditional at 1.5 and 3.0 T, with a sensor designed to measure directly at the source, and is used with Integra’s next-generation Camino monitor, which debuted in 2013. According to Integra, more than 800 centers in the United States use the Camino platform for conditions that cause an elevated intracranial pressure, including traumatic brain injury, subarachnoid hemorrhage, and stroke.

“We are very pleased that our Camino Flex ventricular catheter is approved for MRI scans,” said Peter Ligotti, Integra’s vice president of marketing, neurosurgery. “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.”

When coupled with the Camino monitor, the Camino Flex ventricular catheter provides clinicians access to a full system for the diagnosis and treatment of compromised neurological conditions. The catheter continuously monitors intracranial pressure (ICP) independently in the ventricles, even when cerebrospinal fluid (CSF) flow cannot be established or the catheter is occluded by a blood clot. A multilumen design also reportedly allows for simultaneous CSF drainage and ICP monitoring, providing a continuous measurement of ICP and waveforms. The Camino monitor is a platform designed to incorporate both tunneled and bolted advanced monitoring technologies, which monitor ICP in either the parenchyma or ventricle space. The portable monitor integrates strain gauge and fiber optic monitoring technologies. It features up to five days of patient ICP data trending, and has a large touchscreen interface.

Integra provides implants, devices, instruments, and systems used in neurosurgery, neuromonitoring, neuro-trauma, and related critical care.