RAYNHAM, MA – NOVEMBER 14 , 2011 – Codman & Shurtleff, Inc. (Codman), a global neuroscience and neurovascular company, today announced the launch of the CODMAN® CERTAS™ Programmable Valve, a shunt used in the treatment of congenital or acquired hydrocephalus, an excess accumulation of cerebrospinal fluid (CSF) in the brain.
Over the last 15 years, Codman shunts have been used to treat approximately 150,000 patients suffering from hydrocephalus in the U.S. The CODMAN® CERTAS Programmable Valve is the latest offering in the company’s portfolio of products for the treatment of hydrocephalus, and provides surgeons with another choice when determining the appropriate course of treatment for patients.
The CODMAN® CERTAS Programmable Valve has eight settings to control the rate of drainage of CSF from the brain to the abdomen. The eighth setting is a very high setting comparable to the valve being “off.” The new device, which is resistant to unintended changes to settings during magnetic resonance imaging (MRI)1 , will be offered alongside the CODMAN® HAKIM® Programmable Valve*, a shunt that offers 18 settings.
“The CODMAN® CERTAS Valve is easy to program and still provides doctors with enough settings to make very fine adjustments in pressure to get the best resolution of symptoms after shunt implantation,” said George Jallo, MD, Clinical Director of Pediatric Neurosurgery at Johns Hopkins Hospital, Baltimore. “A device that is resistant to MRI is a big plus for patients.”
The CODMAN® CERTAS Programmable Valve can be integrated with CODMAN® SIPHONGUARD® to prevent excessive flow of CSF while draining, and Codman’s BACTISEAL® Catheters.
“Hydrocephalus is a complex and debilitating condition. We are committed to expanding our solutions to help surgeons advance the treatment of patients who have varying needs,” said P. Laxmin Laxminarain, Worldwide President, Codman. “Codman has been a pioneer in the development of programmable shunt technology and we continue to innovate in this area to help patients overcome their symptoms and live a higher quality of life.”
The CODMAN® CERTAS™ THERAPY MANAGEMENT SYSTEM™ is used to read and adjust the valve setting in an outpatient setting. The Valve and Therapy Management System has been designed so a physician can easily read and adjust pressure settings non-invasively to meet the unique needs of patients.
Excessive accumulation of CSF results in the widening of the brain’s ventricles, which can put harmful pressure on the brain. In infants, this may lead to an unusually large head size and produce symptoms including vomiting, sleepiness, irritability, downward deviation of the eyes and seizures.2 More than 70 percent of hydrocephalus occurs during pregnancy or shortly after birth, as a result of a birth defect.3
Acquired hydrocephalus, which occurs later in life, may be caused by a blockage to the flow of CSF, a brain tumor or cyst, bleeding inside the brain, head trauma or infection. In adults 55 and older, it may cause normal pressure hydrocephalus (NPH), a little-known neurological condition characterized by three primary symptoms: cognitive decline and confusion, walking and balance problems and incontinence. Experts estimate about 375,000 people in the U.S. may have NPH.4
The most common treatment for hydrocephalus is the surgical implantation of a shunt, a flexible tube placed into the brain to divert excess CSF into another region of the body, most often the abdominal cavity. CSF is an essential bodily fluid produced continuously to cushion the brain and spinal cord tissue from injury and maintain a proper balance of nutrients around the central nervous system.
Codman has been a leading supporter of patient and professional education and advocacy for hydrocephalus. In 2005, the company helped to fund the development of international clinical guidelines on NPH by a team of independent medical experts. Codman has also developed two popular websites for patients and caregivers, www.LifeNPH.com and www.hydro-kids.com , where people can obtain information about the diagnosis and treatment of NPH and infant hydrocephalus.
The CODMAN®CERTAS Programmable Valve received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in late October. Conformité Européenne (CE) mark approval was granted in 2010 and the product is currently available throughout Europe.
Potential Risks and Complications
Potential complications of shunt surgery may include infection of the surgical wound or of the CSF (meningitis), bleeding into the brain or ventricles, or a seizure. A shunt infection may be indicated by fever, redness or swelling along the shunt track.
About Codman & Shurtleff, Inc.
Codman is a global neuroscience and neurovascular company that develops and markets a wide range of products and solutions for the diagnosis and treatment of neurological disorders including chronic pain management, adult and pediatric hydrocephalus, neuro critical care, stroke prevention and management. Codman is part of the DePuy Family of Companies within Johnson & Johnson. The DePuy Family of Companies has a rich heritage of pioneering a broad range of products and solutions across the continuum of orthopaedic and neurological care.
*HAKIM is a registered trademark of Hakim USA, LLC and is used under license by Codman & Shurtleff, Inc.
1 The use of Magnetic Resonance (MR) Systems operating at 3 Tesla or less will not damage the valve mechanism and testing shows that the valve is resistant to unintended changes in the setting. However it is recommended that the clinician confirm the valve setting after a magnet resonane.
2 Codman & Shurtleff, Inc. HydroKids. Retrieved from http://www.hydro-kids.com/symptoms
3 Codman & Shurtleff, Inc. HydroKids. Retrieved from: http://www.hydro-kids.com/causes
4 Hydrocephalus Association, www.hydroassoc.org/about-2/media-resources/the-stats/