Likvor CELDA™ System

Likvor CELDA™ System is a medical device that will simplify assessment of cerebrospinal fluid, CSF, dynamics in a safe and reproducible way.

The investigation is an important part for diagnosis and follow-up on patients. Until today, CSF dynamics has been investigated in many ways with mostly non-standardized, non-commercially available equipment. Therefore, it has been difficult to gather, compare and summarize data obtained by research or from clinical investigations.

Likvor CELDA™ System changes the situation for investigators working in the clinic and/or with research. Likvor CELDA® System offers automatic standardized protocols for multiple purposes. This includes precise pressure measurements, preoperative investigations to aid in diagnosis, and postoperative investigations to determine shunt function.

 

Infusion test

The infusion test is used to assess the hydrodynamic properties of the CSF system. Two needles are placed in the spinal canal (lumbar subarachnoid space), connecting to the CSF system. One needle is used for infusion or withdrawal of Ringer solution (artificial CSF). The CSF system is manipulated through the infusion and the corresponding pressure response is measured with the other needle. Consequently, the characteristic parameters of the system can be estimated, including important adherent statistical parameters.

Several infusion tests are used today. They differ in their use of infusion protocols and parameter estimation methods. The infusion can be either passive, with a pre-set infusion rate, or active, with pressure regulation via a controller. These infusion tests are included in the Likvor CELDA™ System and has been evaluated in clinical studies.
Until today, CSF dynamics has been investigated in many ways with mostly non-standardized, non-commercially available equipment. Therefore, it has been difficult to gather, compare and summarize data obtained by research or from clinical investigations

Likvor CELDA™ System changes the situation for investigators working either in the clinic, with research, or both. Likvor CELDA™ System offers automatic standardized protocols for multiple purposes. This includes precise pressure measurements, preoperative investigations to aid in diagnosis, and postoperative investigations to determine shunt function, with constant flow or constant pressure measurements. The Likvor CELDA™ System produces an objective assessment of the results, and the results are independent on the performance of the patient and/or investigator. The produced estimates are reliable and can be interpreted accurately. This will all be beneficial for the patient. With its flexibility and ease of use, the Likvor CELDA™ System sets a new standard for investigations of CSF dynamics.

 

Preoperative investigation

When patients present with typical clinical symptoms indicating possible hydrocephalus, e.g. enlarged ventricles, the CELDA™ Instrument aids in diagnosis and in identifying shunt responders. It is important that the produced estimates are reliable and can be interpreted accurately. An advantage of the infusion test is the objective assessment of the results, and that the results are independent on the performance of the patient and/or investigator.

 

Control of shunt function

The Likvor CELDA™ Instrument is not only unique as the first commercial instrument for better diagnostics of NPH but it is also a superior instrument for testing existing shunt systems. Following a shunt implantation, follow-up visits necessary to evaluate whether unchanged or worsened symptoms can be corrected by shunt adjustment and also to discover any cases of shunt dysfunction requiring surgical shunt revision. Even improved patients could benefit with better adjustment of the shunt. In a pre- and postoperative evaluation with the automatic protocol it is easy to determine if a patient’s shunt works as intended. Using the instrument in postoperative care can avoid many unnecessary operations and can optimize shunt functionality.

 

Pressure measurement

There are different indications for when a pressure measurement should be performed via lumbar space and a lumbar puncture. To investigate intracranial hypertension and hypotension in patients with a chronic, unexplained headache, a pressure measurement is necessary. This is achieved with the CELDA™ Instrument. The most common way of measuring intracranial pressure, ICP, is by using a graded spinal fluid manometer with estimation of the height of the CSF column. This kind of measurement gives only one instant value of ICP, and the result is subjected to errors. With a 30-min ICP measurement offered by the Likvor CELDA™ Instrument it is possible to at look at not only mean ICP of the patient but also the arterial pulsation amplitude and slow waves (i.e. B-waves).