Codman & Shurtleff Inc., part of the Depuy Synthes companies, announced Tuesday that it has received a premarket approval from the U.S. Food and Drug Administration to market a neuromodulation product that treats spasticity.
The MedStream Programmable Infusion System is an implanted device that 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, which isn’t as effective in managing the symptoms of the disease, the company noted in a press release. The FDA approval of the device marks Codman & Shurtleff’s entry into the neuromodulation field.
The MedStream Programmable Infusion System, which is implanted in the abdomen, is already approved in Europe and will be rolled out in a phased launch for the U.S. market. 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.