proSA®

proSA®
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proSA®

Product catalog summary
Introduction
The proSA® Adjustable MIETHKE Shunt Systems are designed to provide precise care for hydrocephalus patients by minimizing overdrainage risks through gravitational technology. The system allows for individual adjustments to accommodate body growth or increased peritoneal pressure.

Specifications
The proSA valve offers a pressure setting range from 0 to 40 cmH2O, allowing for personalized adjustments. It can be combined with any differential pressure valve, making it suitable for a wide range of patients. The titanium shell ensures reliable function regardless of external pressures.

Functionality
The proSA valve automatically adapts its opening pressure based on the patient's body position. In a supine position, the opening pressure is 0 cmH2O, while in an upright position, the pressure is the sum of the gravitational and differential pressure units.

Enhanced Treatment Options
The system can be adjusted to suit individual patient characteristics such as BMI, pregnancy, or pediatric growth. It is recommended to implant the proSA valve with a differential pressure unit, especially for less mobile patients.

Safety and Approvals
The proSA system is MRI-approved up to 3 Tesla and features an "Active Lock" mechanism to prevent inadvertent adjustments by external magnetic fields. The adjustment and verification instruments allow for easy and fast treatment without X-ray exposure.

Clinical Studies and References
Numerous studies and clinical experiences have demonstrated the effectiveness of gravitational shunt systems in reducing overdrainage risks in both pediatric and adult hydrocephalus patients.

Conclusion
The proSA® Adjustable MIETHKE Shunt Systems provide a versatile and reliable solution for hydrocephalus treatment, offering enhanced patient care through its adjustable and adaptive features.
Overview
The document provides detailed information on the roGAV® and BURRHOLE RESERVOIR systems designed for pediatric applications in the treatment of hydrocephalus. It includes specifications, instruments, and the collaborative efforts between Aesculap and Miethke.

Specifications
The systems include adjustable differential pressure units, gravitational units, and various catheters. Key components are the 18 mm adjustable differential and gravitational units, 1200 mm distal catheter, and 180 mm ventricular catheter with introducing stylet. The burrhole reservoir measures 14 mm.

Instruments
The document lists instruments for valve adjustment, including the proSA and proGAV adjustment and verification instruments. These tools are essential for setting and verifying the opening pressure of the valves.

Valve Systems
The document describes various valve systems, including the proSA and proGAV, which are designed for both adult and pediatric hydrocephalus. These systems feature adjustable gravitational and differential pressure valves.

Collaboration and Innovation
Aesculap and Miethke have been collaborating since 1999 to develop innovative solutions for hydrocephalus treatment. Their efforts have led to the introduction of the first gravitational unit for pediatric patients, aimed at preventing cerebrospinal fluid overdrainage.

Conclusion
The document emphasizes the ongoing commitment to research and development in hydrocephalus treatment, highlighting the importance of continued innovation and collaboration to improve patient outcomes.
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Catalog excerpts

proSA®-1

Adjustable MIETHKE Shunt Systems Your Simple Choice for Precise Patient Care Aesculap Neurosurgery

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proSA®-2

Enhanced Patient Care Active people spend about 2/3 of the day walking, standing or sitting upright. Consequently, hydrocephalus patients with a shunt often risk overdrainage. The new proSA is the result of continuous evolution of the proven and accepted gravitational technology. The proSA allows individual adjustment, which can be necessitated by body growth or increased peritoneal pressure. The introduction of the gravitational technology for hydrocephalus treatment brought new options to avoid the symptoms and long-term complications caused by overdrainage. “ The analysis of our material demonstrates...

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proSA®-3

Gravity approved The Miethke valves proGAV, GAV and paediGAV based on this technology offer effective solutions for pediatric and adult hydrocephalus [1,2,3,4,5]. MRI approved Like the proGAV, the proSA features an “Active Lock” mechanism. This mechanism protects the valve against inadvertent adjustment by external magnetic fields and is MR-conditional* up to 3 Tesla [6,7,8,9]. Approved instruments The patented adjustment and verification instruments allow easy, fast and uncomplicated treatment at any location, without having to expose the patient to X-ray [1,9]. * According to the new ASTM (American...

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proSA®-4

Enhanced Treatment Options proSA offers extended options and possibilities for all fields of hydrocephalus treatment, beyond the limitations of conventional adjustable shunt systems. The pressure setting range of 0 to 40 cmH2O allows individual adjustment for each patient. The proSA valve can be combined with any differential pressure valve. One valve fits all patients Wide range of pressure levels for adjustment between 0 to 40 cmH2O Automatic adaption of pressure depending on bodyposition within adjusted pressure range Titanium shell ensures reliable function, independent of external and subcutaneous...

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proSA®-5

Initial Valve Adjustment [cmH2O] The proSA valve should be implanted in combination with a differential pressure unit. The less mobile the patient, the lower the opening pressure to be set. Individual characteristics of the patient, e.g. the Body Mass Index, adiposity, pregnancy, growth of pediatric patients, etc. can be easily adapted for, by adjusting the gravitational unit in the course of the therapy. * These guide values are not binding. Other settings may be preferable depending on the individual patient and anamnesis proSA in X-ray view unused range

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proSA®-6

The Function – Supine Function The proSA is an adjustable gravitational valve whose opening pressure automatically adapts to the patient’s body position. In the supine position, the opening pressure of the proSA is 0 cmH2O. In this mode, the shunt opening pressure is completely defined by the differential pressure unit. Optional differential pressure unit Adjustable gravitational unit Valve opening pressure* (cmH2O) * The graph only represents the opening pressure of the proSA. For the opening pressure of the shunt system as a whole, the opening pressure of the differential pressure unit has...

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proSA®-7

The Function – Upright Function When the patient is in an upright body position, the gravitational unit and the differential pressure unit work together, i.e. the opening pressure of the shunt system as a whole is the sum of the differential pressure level and the pressure level set at the gravitational unit. Optional differential pressure unit Adjustable gravitational unit Adjustment range proSA body position

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proSA®-8

Instruments for Valve Adjustment The proSA is located by palpation. Position the verification instrument according to instruction for use on the valve. Press the trigger button to see the actual opening pressure setting displayed in the display window.

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proSA®-9

Adjustment Select the appropriate opening pressure on the adjustment instrument. Position the instrument according to instruction for use on the valve. Unlock the mechanical coupling “Active-Lock” by applying mild pressure on the trigger button and set the intended opening pressure of the adjustable valve. Any adjustment can easily be confirmed using the verification instrument.

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proSA®-10

proSA® Optional with differential pressure unit proSA® Available as adjustable gravitational unit only or in combination with differential pressure unit no differential pressure unit: with differential pressure unit: 18 mm adjustable gravitational unit Connector: Diff. press. Unit: Catheter: 14.7 mm differential pressure unit 18 mm adjustable gravitational unit Differential pressure unit (not adjustable / cmH2O) optional combination with differential pressure unit * for prevention of reflux only 1

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proSA®-11

proSA® with distal catheter Available as adjustable gravitational unit with integrated distal catheter only or in combination with differential pressure unit no differential pressure unit: with differential pressure unit: 18 mm adjustable gravitational unit Connector: Diff. press. Unit: Catheter: 14.7 mm differential pressure unit 18 mm adjustable gravitational unit Differential pressure unit (not adjustable / cmH2O) optional combination with differential pressure unit FV707T * for prevention of reflux only 11

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proSA®-12

proSA® SHUNT SYSTEM with SPRUNG RESERVOIR Adjustable gravitational unit with integrated distal catheter Adjustable between 0 - 40 cmH2O SPRUNG reservoir* with integrated distal catheter 14.7 mm differential pressure unit *Flushing reservoir allows for the checking of the ventricular catheter’s patency and ensures only distal drainage. 18 mm adjustable gravitational unit Ventricular catheter with introducing stylet introducing stylet 180 mm ventricular catheter Connector: Diff. press. Unit: Catheter: Differential pressure unit (not adjustable / cmH2O) optional combination with differential pressure...

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proSA®-13

proSA® SHUNT SYSTEM with CONTROL RESERVOIR Adjustable gravitational unit with integrated distal catheter Adjustable between 0 - 40 cmH2O Control Reservoir* with integrated distal catheter *Flushing reservoir allows for the checking of the ventricular catheter’s patency and ensures only distal drainage. 14.7 mm differential pressure unit 18 mm adjustable gravitational unit Ventricular catheter with introducing stylet and deflector Connector: Diff. press. Unit: Catheter: introducing stylet Differential pressure unit (not adjustable / cmH2O) optional combination with differential pressure unit FV717T...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.