Medtronic wins CE Mark for Visualase brain surgery device

Medtronic (NYSE:MDT) said today that it won CE Mark approval in the European Union for its Visualase brain surgery device.

Fridley, Minn.-based Medtronic said the MRI-guided Visualase system uses a small-diameter probe to deliver laser energy to ablate soft tissue in the brain. It’s been approved in the U.S. since 2007, the company said.

“The introduction of Visualase to European physicians ensures that more patients will have access to this beneficial technology,” brain therapies president Brett Wall said in prepared remarks. “This latest milestone is a testament to our commitment to expanding therapeutic options for physicians and their patients.”

Medtronic said it’s “involved” in a 150-patient pivotal U.S. study it hopes to use in backing a bid for an expanded indication from the FDA for treating patients with drug-resistant mesial temporal lobe epilepsy. Enrollment in that study is suspended pending a “protocol revision” as of Feb. 14, according to ClinicalTrials.gov.

“After supporting the FDA clearance with our completion of the first in-human study of the Visualase system in 2006 in Paris, I am excited the technology has arrived in Europe,” added Dr. Alexandre Carpentier of Pitie Salpetriere university hospital in Paris.

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