proSA®

Adjustable for the upright body position

FEATURES

  • first adjustable hydrocephalus valve for the standing body position

  • efficient protection against over-drainage through individual and infinitely variable adjustable opening pressure from 0-40 cmH2O

  • quick and easy adjustment

  • MRI-compatible up to 3 Tesla: no X-ray control after MRI necessary, no additional radiation exposure for the patient

  • "Active Lock" mechanism: protected against unintentional adjustment by means of exposure to magnets found in daily life, such as those used in smartphones, toys, induction cookers or safety barriers at the airport

  • precise precision engineering

  • robust and durable due to the use of titanium

FUNCTIONALITY

The proSAis composed of a robust titanium casing whose proximal end contains a ball-cone valve. A coil spring determines the opening pressure of the ball-in-cone valve and the sapphire ball ensures the precise closure of the valve.The weight is connected to the spring and keeps the sapphire ball in its position. In this way, optimal CSF drainage is ensured for each individual patient in any body position. The tension of the spring, and thus the valve opening pressure, can be adjusted by turning the rotor magnetically, with the valve implanted under the patient's skin. 

Horizontal Position

The gravitational unit is always open in the lying position and does not represent any resistance. Thus the opening pressure of the proSA in the horizontal body position is determined exclusively by the differential pressure unit. It remains closed and prevents CSF drainage until the patient's intracranial cerebral pressure (ICP) rises to such an extent that the set spring force that otherwise keeps the ball closed is overcome. The closing ball moves out of the cone and thus allows the corresponding cerebrospinal fluid drainage.

Vertical Position

In the vertical position, the proSAand the differential-pressure valve work together. The total opening pressure is the sum of the opening pressures of the DP-valve and the proSA. If the IVP (intraventricular pressure) of the patient and the hydrostatic pressure exceed this pressure, the closing ball of the proSAis pushed away from the cone seal and a gap opens for fluid drainage. The valve system prevents increases in intraventricular pressure above the physiological range.

VALVE ADJUSTMENT

The patented adjustment and verification instruments allow easy, fast and uncomplicated treatment at any location, without having to expose the patient to X-ray radiation. The unique "Active-Lock" mechanism protects the proSA against accidental re-adjustment by external magnetic fields.

Due to the wide range of opening pressures (0-40 cmH₂O) available on the proSA, there are numerous possible treatment options.

Furthermore the range of angular rotation for adjustment is 300°, ensuring excellent adjusting precision.

1. LOCALIZE

Weiterlesen

First, locate the proSA feeling the implantation location. The proSA VERIFICATION COMPASS is an auxiliary instrument for locating the proSA.

As the proSA VERIFICATION COMPASS is held above the valve, the floating disc aligns over the adjustable unit of the proSA. The current opening pressure setting can be read from the compass scale.

2. CHECK

Weiterlesen

Position the proSA VERIFICATION TOOL centrally over the valve. The marking and the readout display on the proSA VERIFICATION TOOL must be in line with the proximal (ventricular) catheter. Press the trigger button to see the actual opening pressure setting displayed on the readout.

3. ADJUST

Weiterlesen

Select the appropriate opening pressure on the proSA VERIFICATION TOOL.

Position the proSA VERIFICATION TOOL centrally over the valve. The marking and the readout display of the proSA VERIFICATION TOOL must be in line with the proximal (ventricular) catheter. Unlock the rotor ("Active-Lock") by applying mild pressure on the trigger button and then check the setting with the proSA VERIFICATION TOOL.

Learn more about the proSA adjustment tools
About the Tools

 

proSA® adjustable unit

PRESSURE LEVEL DETECTION IN X-RAY IMAGE

The set pressure level setting of the proSA can be reliably checked at any time with the proSA test instrument without additional X-ray examination.

For detection in the X-ray image we recommend the use of the MIETHKE App. Here, the valve can be individually adjusted according to the X-ray image and a template can be used to reliably read off which pressure level the proSA represents in the X-ray image (in the picture on the right: 4 cmH2O). The recess (on the left side) serves as an orientation in order to ensure thet the pressure level is not inadverently misread.

The selection of the appropriate pressure level of the proSA depends on several factors, including the patient's age, degree of activity, height and stature of the patient. For further information, please refer to our pressure level recommendation.

 

 

MIETHKE APP - UNDERSTANDING VALVES EASILY


The MIETHKE App shows clearly and quickly understandable how our valves work:

+ Influence of the body position on the opening pressure: The motion sensor of the smartphone simulates the body position of the patient: upright - inclined - lying.

+ Pressure stage recognition in the X-ray image: Every set or preset pressure stage is shown here and can be easily recognized by means of templates.

+ Simulation of adjustability: Valves can be easily adjusted with the finger and thus help to understand what is happening inside the valve.

+ View into the inside of MIETHKE valves: All valves allow a view of their construction and thus the influence of the cerebrospinal fluid flow on the functioning can be shown in an easily understandable way.

+ free for Apple and Android
 

   

proSA®

Download Information

proSA_Gebrauchsanweisung_-_Instructions_for_use.pdf

Instructions for use

proSA_Patientenhandbuch_-_Patient_Manual.pdf

Patient Manual

DO YOU HAVE ANY QUESTIONS ABOUT THE PRODUCT?
WE ARE THERE FOR YOU.

Thoralf Knitter

Head of Research & Development

Roland Schulz

Head of Product Management

Thammo Weise

Product Management

Andreas Bunge

Product Management

Michaela Funk-Neubarth

Head of Marketing & HR

Jan Mügel

Product Management

Josefine Kehl

Deputy Head of Marketing & Corporate Communications

August von Hardenberg

Product Management

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OUR PARTNERSHIP
WITH B. BRAUN

B. Braun and MIETHKE - Together for a better life with hydrocephalus

We have a long and intensive partnership with B. Braun in the field of neurosurgery. We are driven by a common vision: to improve the lives of hydrocephalus patients around the world with innovative solutions.

Our partnership is an exciting combination of B. Braun's nearly 180 years of expertise as one of the world's leading medical device and pharmaceutical companies and our agility as an innovative company and technology leader in gravitation-based shunt technology. 

 

Our strong partner in neurosurgery:

www.bbraun.com