European launch of the CODMAN® CERTAS™ Programmable Valve, a new programmable valve used to treat congenital or acquired hydrocephalus, an excess accumulation of cerebrospinal fluid (CSF) in the brain.
Codman Expanding Shunt Solutions for Congenital or Acquired Hydrocephalus RAYNHAM, MA – APRIL 26, 2011 – Codman & Shurtleff, Inc. today announced the European launch of the CODMAN® CERTAS™ Programmable Valve, a new programmable valve used to treat congenital or acquired hydrocephalus, an excess accumulation of cerebrospinal fluid (CSF) in the brain.
The CODMAN CERTAS Programmable Valve has seven settings for different rates of drainage of CSF, and an eighth “Virtual Off” setting. The device is highly resistant to magnetic resonance imaging (MRI) and may be integrated with the CODMAN® SIPHONGUARD® to prevent excessive flow of CSF while draining and Codman’s BACTISEAL® Antimicrobial Catheter System.
“Patients have different needs when it comes to the level and rate of drainage required to relieve symptoms,” said Bertil Romner, MD, Chair Professor of the Department of Neurosurgery at the University of Copenhagen,* who has begun treating hydrocephalus patients with the CODMAN CERTAS Programmable Valve in Copenhagen, Denmark. “For many, eight pressure settings may be enough, for others, the full range of 18 settings offered by the CODMAN® HAKIM® Programmable Valve HAKIM is a registered trademark of Hakim USA, LLC and is used under license by Codman & Shurtleff, Inc. (the current valve offered by Codman) may be required to optimize treatment.”
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.1 More than 70 percent of hydrocephalus occurs during pregnancy or shortly after birth, as a result of a birth defect.2
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 condition that affects about 23 out of every 100,000
people annually and produces Alzheimer's-like symptoms including difficulty walking, dementia
and incontinence..3,4,5 The newly developed CODMAN CERTAS™ THERAPY MANAGEMENT SYSTEM™, which consists of a locator tool, an indicator tool and an adjustment tool, is used with the new valve to increase or reduce the flow of CSF in an outpatient setting, if an adjustment is necessary after surgery. The valve and management system have been designed so a physician can easily read and adjust pressure settings non-invasively to meet the unique needs of patients.
“Hydrocephalus can be one of the most debilitating disorders neurosurgeons treat, though not necessarily the most common,” said P. Laxmin Laxminarain, Worldwide President, Codman & Shurtleff. “With the launch of the CERTAS Programmable Valve, we are providing a new choice for hydrocephalus that builds on our proven shunt technology, enhances versatility, and offers greater ease of operation
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.
The CODMAN CERTAS Programmable Valve received Conformité Européenne (CE) mark approval in the fourth quarter of 2010. CE mark approval indicates that the product conforms with the essential health and safety requirement set out in the European Directives. The product is indicated for use in the treatment of hydrocephalus in infants and adults and can be promoted in all Member States of the European Union (EU), European Economic Area and Switzerland. The CERTAS Programmable Valve is not available for sale in the United States.
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, aneurysm and 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. These companies are unified under one vision – Never Stop Moving™ – to express their commitment to bring meaningful innovation, shared knowledge and quality care to patients throughout the world. Visit www.depuy.com for more information.
*Paid consultant to Codman
1 Codman & Shurtleff, Inc. HydroKids. Retried from http://www.hydro-kids.com/symptoms
2 Codman & Shurtleff, Inc. HydroKids. Retrieved from: http://www.hydro-kids.com/causes
3 Normal Pressure Hydrocephalus - Arif I Dalvi, MD, Director, Movement Disorders Center, NorthShore University HealthSystem, Clinical Associate Professor of Neurology, University of Chicago Pritzker Medical School, Jan 1992;42(1):54-9.
4 Brean A, Eide PK. Prevalence of probable idiopathic normal pressure hydrocephalus in a Norwegian population. Acta Neurol Scand. Jul 2008;118(1):48-53. [Medline].
5 Marmarou A, Young HF, Aygok GA. Estimated incidence of normal-pressure hydrocephalus and shunt outcome in patients residing in assisted-living and extended-care facilities. And which demographic gets this most? Neurosurgical Focus 2007; 22: 1-8.