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Medical Devices / Regulatory Affairs / Postmarket Safety / Submissions and Approvals

Integra’s Camino Flex Ventricular Catheter Gets FDA OK for MRI

April 7, 2014

The FDA has granted Integra LifeSciences 510(k) clearance to use its Camino Flex ventricular catheter in magnetic resonance imaging scans.

Up to this point, Integra’s 1.5 and 3.0 T catheter was MR conditional. The new clearance means that patients undergoing neuromonitoring with Camino Flex can undergo scans without having to have the catheter removed. This is especially beneficial for patients whose management protocol includes both drainage of cerebrospinal fluid and follow-up imaging, said Integra spokesman Peter Ligotti.

The device contains a sensor that measures directly at the source and is meant to be used with the company’s Camino monitor. According to the company, system provides continuous monitoring of intracranial pressure in the ventricles under normal circumstances, as well as when CSF flow can’t be determined accurately or when there is a blood clot. Its multilumen design allows for ICP monitoring and draining of cerebrospinal fluid.

The Camino Flex monitor turns out data for up to five days, providing a large touchscreen interface. — Lena Freund

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