Living a Meaningful Life

Growing up, Snow Tseng has always loved the outdoors – hiking, swimming, playing golf. All of that came to a halt when he was diagnosed with a brain tumor while pursuing his graduate studies in Chicago. Over time, Snow developed symptoms such as slurred speech, impaired vision, and hydrocephalus.

Despite having a shunt to treat his hydrocephalus, the disease kept affecting Snow’s life, in many ways. As his hydrocephalus symptoms worsened, it became more and more difficult for Snow, who is a university professor, to continue to have a normal life. One day, the shunt he had for more than 20 years eventually clogged and rendered Snow unconscious. He had to be taken to the emergency room to address the shunt malfunction.

Doctor Robert Hsin-Hung Chen, Snow’s surgeon for more than 20 years, performed several surgeries on Snow. He decided to insert the CODMAN® CERTAS® Plus Programmable Valve, an implantable device that provides constant intraventricular pressure and drainage of the Cerebrospinal Fluid (CSF) for the management of hydrocephalus.

"Luckily with a programmable shunt, it allows more freedom, and we had the option to adjust the shunt pressure from outside without actually performing a brain surgery. To me, as a patient, that’s a huge plus!," said Snow.

Note: Clinical results may vary.

Product Information

CERTAS® Plus

Indications for use

The CERTAS® Plus Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

 

Contraindications

These devices are contraindicated in patients receiving anticoagulants or known to have a bleeding diathesis.

Avoid shunt implantation if infection is present within the body. Delay the shunt procedure when infections such as meningitis, ventriculitis, peritonitis, bacteremia, and septicemia are present.

The BACTISEAL® catheters are contraindicated in patients with known hypersensitivity to rifampin or clindamycin hydrochloride.

 

Warnings

Choose an implantation site for the valve where the tissue over the valve is not too thick (i.e. tissue thickness <10 mm). Otherwise locating, reading, and adjusting the valve with the tool kit may be difficult (i.e.; multiple attempts may be required) or impossible. If unable to adjust the valve, the valve will maintain a constant operating pressure and the patient should be informed of this risk (see Tool Kit Instructions for Use for more information).

As with all programmable valves, the magnets within the CERTAS® Plus valve will cause an image artifact on CT and MRI imaging. As a result, the implantation site should be chosen so that the artifact will be minimized in areas of significant clinical interest, such as a tumor, that may require repeated future imaging assessment.

Testing shows that the valve mechanism is resistant to unintended changes in the setting in a 3 Tesla MRI. However, the clinician should confirm the valve setting after a magnetic resonance imaging (MRI) procedure.

The valve setting is adjusted with the application and manipulation of strong magnets. A change to the valve setting is unlikely to occur under normal circumstances. However, magnetic fields should not be placed near the valve due to the possibility of an unintentional setting change.

Read MRI Information before performing an MRI procedure on a patient implanted with the valve.

Any magnet may experience a degradation of magnetic field strength as a consequence of exposure to the significantly stronger magnet field induced in an MRI procedure.

  • Based on the coercivity of the CERTAS® Plus magnet material, the valve is resistant to magnetic degradation in a 1.5T MRI.
  • Testing of the CERTAS® Plus valve following exposure to 10 simulated MRI procedures at 3T indicates there is no substantial demagnetization or significant reduction in programmability. Please refer to the Tool Kit IFU if any difficulty in programming occurs.

 

Precautions

Inspect the sterile package carefully. Do not use if:

– the package or seal appears damaged,

– contents appear damaged, or

– the expiry date has passed.

Use sterile technique in all phases of handling the valves and accessories.

Use only with catheters that are compatible with the dimensions shown in the Detailed Product Description section of the Instructions for Use.

Ventriculoatrial (VA) shunting could be considered in patients when:

-        peritoneal CSF absorption is impeded and alternative sites for shunting are necessary

-        the patient presents with peritoneal adhesions, pseudocysts or dialysis catheters

Surgeons should consider the additional risks and benefits prior to considering a VA shunt:

-        in patients with cardiopathies or other malformations of the cardio-pulmonary system

-        in children, VA distal catheter location is more crucial for proper function, since rapid growth may cause cephalad migration of the tip over time

The safety and effectiveness of Bactiseal catheters for VA shunting has not been established.

Carefully monitor the patient during the first 24 hours after adjusting the valve setting. It is recommended that each adjustment be limited to an increase or a decrease of one setting, since setting changes can range between 15 and 50 mmH2O.

The valve setting should be confirmed after an MR procedure.

Use only a CERTAS® Tool Kit to adjust the setting of the CERTAS® and CERTAS® Plus Programmable Valves.

Excessive swelling may make it difficult to determine and/or adjust the performance setting.

-        If difficulty correctly positioning the Tool persists, see the Tool Kit IFU.

Integra has not evaluated the effect of having other medical devices implanted in close proximity to the CERTAS® Plus Valve.