Codman & Shurtleff Drug Delivery System Gains FDA Approval
Posted on August 8, 2012 @ 12:04 pm
Codman & Shurtleff Inc., a neurological device company based in Raynham, Mass., has been granted U.S. Food and Drug Administration (FDA) approval for its Medstream Programmable Infusion System, an implantable infusion pump and catheter system used in the treatment of spasticity, a movement disorder often caused by stroke, cerebral palsy, multiple sclerosis or spinal cord injury. The device will be available through a phased roll out in the United States over the next several months.
The Medstream System is designed to deliver a continuous and accurate dose of the anti-spasm drug baclofen directly to the spinal canal to relieve the severe spasticity, a condition that affects more than 12 million people worldwide. Codman claims the battery system in Medstream will last eight years, even with the high flow rates in use. Medstream also uses the Surestream Intraspinal Catheter, a purportedly kink-resistant catheter designed to deliver uninterrupted therapy.
"Neuromodulation is an important area in need of innovations that improve accuracy, reliability and device longevity," said Stan Fisher, M.D., co-director at the Methodist Neurological Institute’s Movement Disorders and Neurorehabilitation Center in Houston, Texas, and assistant professor of neurology at Weill Cornell Medical College in New York, N.Y. Fisher is a paid consultant of Codman & Shurtleff.
Medstream has a ceramic drive system whose function is to precisely control drug dosage. This system uses no gears, motors or rotating parts that could wear or stall. Medication is delivered within 10 percent of the programmed flow rate and the device is certified for use in 3-Tesla (measurement of magnetic force) MRI systems.
Use of Medstream involves the implantation of a pump about three inches in diameter and one inch thick into the patient’s abdomen. Baclofen is then transported from the pump directly to the spinal area with the Surestream Catheter. Clinicians use a computerized wireless control unit to non-invasively program dosing and flow rate for each patient based on his or her specific needs.
“The Medstream System is an important advancement that may help thousands of patients suffering from spasticity improve function," said P. Laxmin Laxminarain, worldwide president of Codman. "We are committed to developing products that can make a meaningful difference in people's lives and lessen the global burden of neurological disease."
Delivery of baclofen with implantable infusion devices has been shown to reduce side effects compared to oral administration of the drug. Infusion therapy is not a cure for spasticity, but may help manage its symptoms.
Codman & Shurtleff is part of the DePuy Synthes Companies of Johnson & Johnson.
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