FDA pre-market approval for implantable device to treat spasticity

Published date : 13 August 2012
Article date : 13 August 2012

Codman & Shurtleff Inc., part of the Depuy Synthes companies, has received a premarket approval from the FDA to market a neuromodulation product that treats spasticity. 

The MedStream Programmable Infusion System is implanted in the abdomen and can deliver antispasm drug baclofen directly into the spinal canal through a catheter to relieve the symptoms of severe spasticity. Spasticity affects 12 million in the U.S. and is a movement disorder often caused by stroke, cerebral palsy, multiple sclerosis or spinal cord injury. The device is intended to be an alternative for taking drugs orally.

The pump is about 3 inches in diameter and about 1-inch thick, and is attached to the SureStream Catheter that transports the drug into the spinal canal. Doctors use a computerized control unit to wirelessly deliver correct drug dosage and rate of flow for each patient.

The MedStream Programmable Infusion System is already approved in Europe and will be rolled out in a phased launch for the U.S. market.

Source: medcitynews.com, August 7, 2012

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