Brain Devices

Covidien Recalls Pipeline and Alligator Brain Embolism Devices

04/15/2014

Covidien is voluntarily recalling some of its Pipeline and Alligator Brain Embolism devices after discovering a potentially lethal problem with the guidewires.  The guidewires are coated with a plastic designed to reduce friction.  The problem arises when the plastic coating on the guidewire delaminates and detaches from the devices, which could potentially lead to embolic occlusion with the risk of stroke and/or death.  32 Pipeline embolization devices and 621 Alligator retrieval devices are affected by this recall. Read more about Recalls.
[1] Recall -- Firm Press Release, "Covidien Implements Voluntary Recall of its Pipeline(™) Embolization Device and Alligator(™) Retrieval Device," April 11, 2014.

Clinical Registry Evaluates Vercise Brain Stimulation System for Parkinson's Disease
04/15/2014
Boston Scientific has launched a clinical registry to evaluate the Vercise deep brain stimulation (DBS) system for Parkinson's disease.  Researchers will follow up to 300 patients implanted with the neurostimulator that targets areas of the brain associated with movement disorders.  The device is already sold in Europe, Israel, Australia, and parts of Latin America.  In the U.S., the device has investigational approval from the FDA , but is not yet approved for sale.
[1] Sarvestani, A. "Boston Scientific launches Parkinson's brain stim registry," Mass Device, April 14, 2014.

FDA Approves First Device to Prevent Migraines
03/13/2014
FDA has approved Cefaly, the first transcutaneous electrical nerve stimulation (TENS) device to prevent migraine pain.  Cefaly is a battery-powered device worn across the forehead that provides mild electrical stimulation to the trigeminal nerve, the nerve which is associated with migraines.  According to the device maker, STX-Med, the device is meant to be used once daily for 20 minutes.  Although no serious side effects were reported, the user may feel tingling or massaging sensation where the applied electrode touches the skin.

[1] U.S. National Library of Medicine, NIH, "First Device Approved to Prevent Migraines," HealthDay (March 12, 2014).

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