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The Sophysa external CSF drainage catheters are intended to temporarily drain the Cerebrospinal Fluid (CSF), for less than 30 days (up to 29 days maximum).

The Sophysa external CSF drainage catheters are intended to temporarily drain the Cerebrospinal Fluid (CSF), for less than 30 days. There are two types of external CSF drainage catheters: - Ventricular catheters - Lumbar catheters The catheter is provided sterile and with accessories to facilitate the surgical procedures and connectors. The external CSF drainage catheters need to be connected to collection systems.

The Electronic Reading Instrument is intended to locate and read the operating pressure of a Polaris valve. It is specifically designed to be combined with the Locator from a compatible Polaris Adjustment Kit (PAK2).

The Polaris® valve electronic reading instrument (PAK3-ERI) is intended to non-invasively locate and read the operating pressure of a Polaris® valve before and after implantation in the treatment of hydrocephalus. It should be inserted into the PAK2-LI locator tool (identical to the locator tool part as in the predicate device cleared via K141227) in order to read the valve's pressure position.

The Pressio® 2 Intracranial Pressure Monitoring system is indicated for continuous invasive monitoring of intracranial pressure by trained personnel of (neuro) intensive care units and neurosurgery departments. Depending the type of catheter used, the Pressio® 2 ICP Monitor can also display the intracranial temperature. According to the clinical situation, users choose the appropriate Pressio® catheters: - Pressio® kit for monitoring intracranial parenchymal pressure and temperature with bolt (PSO-PBT) indicated for use in parenchymal pressure and temperature monitoring. - Pressio® kit for monitoring intracranial parenchymal pressure and temperature with tunneling (PSO-PTT) indicated for use in parenchymal pressure and temperature monitoring. - Pressio® kit for monitoring intracranial ventricular pressure and temperature with tunneling (PSO-VTT) indicated for use in intraventricular pressure and temperature monitoring and cerebrospinal fluid drainage application. The following Pressio® kits for Intracranial Pressure Monitoring are also compatible with the Pressio® 2 ICP Monitor: - Pressio® kit for monitoring intracranial parenchymal pressure with bolt (PSO-PB) indicated for use in parenchymal pressure monitoring - Pressio® kit for monitoring intracranial parenchymal pressure with tunneling (PSO-PT) indicated for use in parenchymal pressure monitoring. - Pressio® kit for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application.

The Pressio® 2 ICP Monitoring System is composed of a monitor (PSO-4000) with accessories and implantable catheters. The PSO-4000 monitor is an electromedical device designed for monitoring patient's intracranial pressure and temperature via catheters implanted in parenchyma (PSO-PBT and PSO-PTT) or in ventricles with drainage of cerebrospinal fluid (PSO-VTT). Previously marketed Pressio® kits (K062584) are also available on the Pressio® 2 ICP Monitor and allows monitoring of intracranial pressure via catheters implanted in parenchyma (PSO-PB and PSO-PT) or in ventricles (PSO-VT) with also drainage of cerebrospinal fluid. The Pressio® 2 ICP Monitor can also be connected to a patient monitor via a compatible monitor connection cable. This connection is not necessary for Pressio® 2 Intracranial Pressure Monitor functioning. The Pressio® 2 Monitor can also extract data to external computer via a USB cable. The Pressio® 2 ICP Monitoring System is sold as a kit containing a Pressio® 2 ICP Monitor (PSO-4000), a power supply cable (PSO-AC), a catheter extension cable (PSO-EC30).

The Polaris® Adjustable Pressure Valve is designed for the treatment of hydrocephalus by shunting the Cerebrospinal Fluid (CSF) to the abdominal cavity or right atrium of the heart.

Polaris Pressure Adiustable Valve System / Polaris Adjustable Valve with SiphonX / Polaris Adjustment Kit

The SiphonX® gravitational anti-siphon device is designed to control the siphon effect during the treatment of hydrocephalus by shunting Cerebrospinal Fluid CSF).

The SiphonX® Gravitational Anti-sibhon Device is a siphon requlating accessory device used in the treatment of hydrocephalus. SiphonX® Gravitational Anti-siphon Device is an implantable, single-use device. The SiphonX® Gravitational Anti-siphon Device consists of a plastic housing with integral inflow and outflow channels that are separated by a conical valve seat. The housing contains a weight ball that rests upon a smaller, orifice-sealing ball. The device contains two silicone seals. Gravitational effect is provided by a weight ball which pushes on the valve sealing ball, under the effect of gravity, as the device transitions from a horizontal to a vertical position. The cerebrospinal fluid (CSF) flows in through the inlet connector, past the orifice-sealing ball and flows out by way of the outlet connector when the fluid pressure is greater than the sum of the pressure exerted by the weight ball and the operating pressure of the valve. When the SiphonX® Gravitational Anti-siphon Device is in a horizontal position, no resistance to the flow is provided by the weight ball and orifice-sealing ball thereby allowing CSF to flow freely as regulated by the upstream shunt. On the contrary, when the SiphonX® Gravitational Antisiphon Device is in a vertical position, maximum CSF resistance is applied as the weight ball presses on the orifice-sealing ball. The CSF is directed towards the orifice-sealing ball creating an opposing force to that which is generated by the weight ball. Upon sufficient CSF flow and combined valve pressure and Gravitational Anti-siphon Device pressure, CSF is able to push up the orifice-sealing ball and weight ball and flow through the outlet channel and connector. The device will be distributed by itself or in combination with the Polaris® and Sophy® Pressure Adiustable valves and valve kits.

To drain cerebrospinal fluid (CSF) for the management of hydrocephalus.

The Polaris® Adjustable Pressure Valve is an implantable device designed for the treatment of hydrocephalus in adult and pediatric patients by shunting, thereby providing continuous, controlled intraventricular pressure and CSF drainage from the cerebral ventricles. Intraventricular pressure is maintained at a constant level by the device's ball- in-cone valve seat design, and the value is pressure-adjustable transcutaneously. Drainage is directed to the abdominal cavity or to the right atrium of the heart. The basic settings of the Polaris® Valve Models SPV, SPVA, and SPVB are 30, 70, 110, 150 and 200. Adjustments to intermediate pressures are made manually in 40-50 mm Hz0 increments (decrements) in three operating ranges, low pressure (LP =30 mm Hz0), medium pressure (MP = 110 mm H20), and high pressure (HP = 200 mm H20). The basic settings of the Polaris® SPV-140 Valve are 10, 40, 80, 110 and 140 mm H₂0; adjustments to intermediate pressures are made manually in 30-40 mm H20 increments (decrements). The basic settings of the Polaris® SPV-300 Valve are 50, 100, 150, 220 and 300 mm H₂0; adjustments to intermediate pressures are made manually in 50-80 mm H20 increments (decrements). The basic settings of the Polaris® SPV-400 Valve are 80, 150, 230, 330 and 400 mm H-0; adjustments to intermediate pressures are made manually in 70-100 mm H20 increments (decrements). The specific feature of the self-locking rotor-shuttle micro-magnet system of the passive Polaris® SPV Valve is that the adjustment position of each pressure setting cannot be changed by a unidirectional magnetic field. A domestic field or an exposure to MRI attracts the shuttles in the same direction and thus cannot unlock them simultaneously, therefore the rotor cannot be mobilized and the pressure setting remains fixed and constant.

The Pressio® Ventricular Intracranial Pressure Monitoring Kit with Tunneling, Model PSO-VT, is indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage applications. The Pressio® Intracranial Parenchymal Pressure Monitoring Kit with Tunneling, Model PSO-PT, is indicated for use in subdural or parenchymal pressure monitoring. The Pressio® Intracranial Parenchymal Pressure Monitoring Kit with Bolt, Model PSO-PB, is indicated for use in parenchymal pressure monitoring.

The Pressio® ICP Monitoring System (PSO-3000) is an electromedical device designed for the monitoring of a patient's intracranial pressure (ICP) via a catheter implanted in the parenchyma (PSO-PB or PSO-PT) or in the ventricles (PSO-VT). The Pressio® ICP Monitoring System is sold as a kit containing a Pressio® ICP Monitor (PSO-3000), a Power Supply Cable (PSO-AC) and the Catheter Extension Cable (PSO-EC20). The Pressio® ICP Monitor can be connected to a patient monitor via a compatible monitor connection cable (PSO-MCxx). This permits medical staff to display intracranial pressure curves on the patient monitor. This connection is not necessary for Pressio™ Intracranial Pressure Monitor functioning. The calibration of patient monitor is performed via a host monitor calibration key on Pressio™ Intracranial Pressure Monitor. The Pressio® ICP Monitoring System is composed of the following: - Pressio® ICP Monitor (PSO-3000) - Pressio® ICP Catheters: there are three available types of implantable . catheters: - Catheter implanted in ventricles via tunnelling (PSO-VT) . - Catheter implanted in parenchyma via tunnelling (PSO-PT) . - Catheter implanted in parenchyma via a bolt (PSO-PB) . - . Pressio® Serial Transmitter Model (PSO-TX00) - . Pressio® Intracranial Pressure Interface Control Unit (PSO-IN00) - Catheter Extension Cable (PSO-EC20) . - Monitor Connexion Cable (PSO-MCxx): "xx" depends on the type of . patient monitor available in the hospital, it exists 9 different references - Power Supply Cable (PSO-AC) . - Pressio® Pole Clamp (PSO-CL) . - . Pressio® Disposable Hand Drill (PSO-DR)

To drain cerebrospinal fluid (CSF) for the management of hydrocephalus

The Polaris® Pressure Adjustable Valve models SPV-140, SPV-300, SPV-400 is an implantable device designed for the treatment of hydrocephalus in adult and pediatric patients by shunting, thereby providing continuous, controlled intraventricular pressure and CSF drainage from the cerebral ventricles. Intraventricular pressure is maintained at a constant level by the device's ballin-cone valve seat design, and the value is pressure-adjustable transcutaneously. Drroinage is directed to the abdominal cavity or to the right atrium of the heart. The basic settings of the Polaris® SPV-140 Valve are 10, 40, 80, 110 and 140 mm H₂O; adjustments to intermediate pressures are made manually in 30 mm H20 increments (decrements). The basic settings of the Polaris® SPV-300 Valve are 50, 100, 150, 220 and 300 mm H2O; adjustments to intermediate pressures are made manually in 50-70 mm H20 increments (decrements). The basic settings of the Polaris® SPV-400 Valve are 80, 150, 230, 330 and 400 mm H2O; adjustments to intermediate pressures are made manually in 70-100 mm H20 increments (decrements). The specific feature of the self-locking rotor-shuttle micro-magnet system of the passive Polaris® SPV Valve is that the adjustment position of each pressure setting cannot be changed by a unidirectional magnetic field. A domestic magnetic field or an exposure to MRI attracts the shuttles in the same direction and thus cannot unlock them simultaneously, therefore the rotor cannot be mobilized and the pressure setting remains fixed and constant.

To drain cerebrospinal fluid (CSF) for the management of hydrocephalus

The Polaris® Pressure Adjustable Valve is an implantable device designed for the treatment of hydrocephalus in adult and pediatric patients by shunting, thereby providing continuous, controlled intraventricular pressure and CSF drainage from the cerebral ventricles. Intraventricular pressure is maintained at a constant level by the device's ball-in-cone valve seat design, and the value is pressure-adjustable transcutaneously. Drainage is directed to the abdominal cavity or to the right atrium of the heart. The basic settings of the Polaris® Valve are 30, 70, 110, 150 and 200. Adjustments to intermediate pressures are made manually in 40 mm Hy0 increments (decrements) in three operating ranges, low pressure (LP = 30 mm H20), medium pressure (MP = 110 mm H20), and high pressure (HP = 200 mm H20). The specific feature of the self-locking rotor-shuttle micro-magnet system of the passive Polaris® SPV Valve is that the adjustment position of each pressure setting cannot be changed by a unidirectional magnetic field. A domestic magnetic field or an exposure to MRI attracts the shuttles in the same direction and thus cannot unlock them simultaneously, therefore the rotor cannot be mobilized

To drain cerebrospinal fluid (CSF) for the management of hydrocephalus

The Sophy® Pressure Adjustable Valve System SM8 is an implantable device designed for the treatment of hydrocephalus in adult and pediatric patients by shunting, thereby providing continuous, controlled intraventricular pressure and CSF drainage from the cerebral ventricles. Intraventricular pressure is maintained at a constant level by the device's ball-in-cone valve seat deign, and the value is pressure-adjustable transcutaneously. Drainage is directed to the abdominal cavity or to the right atrium of the heart. The Sophy® Pressure Adjustable Valve System SM8 technology allows for the non-invasive manual adjustment of the operating pressure via 8 pressure settings, ranging from 30 mm H20 to 200 mm H20, as follows: 30 = Low, 110 = Medium (intermediate 50, 70, 90) and 200 = High (intermediate 140, 170). The principle of the Sophy® Pressure Adjustable Valve System SM8, nearly identical to that of its predicate Sophy@SU8 FDA cleared hydrocephalus valve (K992465), is based on the pressure change exerted on a synthetic ruby ball by a semi-circular spring at different points of its curvature. This spring is connected to a magnetic rotor whose position can be adjusted noninvasively by using a adjustment magnet oriented at different angles with selected orientations corresponding to different pressures. Radio-opaque identification dots indicate three main positions of the rotor corresponding to Low, Medium, and High operating pressures. For manual pressure setting, a specific adjustment kit is necessary, including a compass, magnet, and pressure selector. The Sophy® Pressure Adjustable Valve System SM8 is a miniaturized version of the predicate Sophy®SU8 (K992465), with a nearly 50% volume reduction and an approximately 45% weight reduction.