Catalogue 2023 Digit en
Catalogue 2023 Digit en
External Drainage
Catalog
Neuromonitoring
Subcutaneous
Access Ports
Sophysa Catalog
INTRODUCTION
Know more
on Sophysa
Sophysa Catalog
CONTENTS
Hydrocephalus 4
Adjustable Valves 5
Monopressure Valves 16
Anti-Siphon 19
Catheters 20
Reservoirs 30
Connectors 36
Accessories 39
External Drainage 40
External CSF Drainage Systems 41
External CSF Drainage Catheters 43
External CSF Drainage Kits 45
Neuromonitoring 46
Pressio ® 2 ICP Monitor 47
Pressio ® Catheters 48
Pressio ® Accessories 48
NOTE:. Products are not available in all markets. Product availability is subject
to regulatory approval or clearance requirements for sale in respective markets.
Depending on local regulations, the availability of products may vary. Images and
diagrams are not to scale. Information included in this catalog do not replace
Instructions for Use; always refer to Instructions for Use for complete information.
All product, product specifications and data are subject to change without notice.
HYDROCEPHALUS
HYDROCEPHALUS
CONTENTS
Adjustable Valves 5 Reservoirs 30
MRI-Stable Adjustable Valves - Polaris ® 5 CSF Reservoirs - Standard 30
Adjustment Kit - Polaris ® 9 CSF Reservoirs - Convertible 33
Sophy ® Mini SM8 10 CSF Reservoirs - Inline Shunt Reservoir 35
Sophy ® Adjustment Kit - SAK 15
Connectors 36
Monopressure Valves 16 2-ways 36
Sophy Mini SM1
®
16 3-ways 38
4
HYDROCEPHALUS
MRI-Stable Adjustable Valves
Polaris ®
The Polaris® Adjustable Valve is a ball-in-cone valve, with a self-locking magnetic rotor.
Its pressure can be adjusted percutaneously with a dedicated adjustment kit.
Each Polaris® Valve model offers 5 operating pressure levels.
The operating pressure range of the standard Polaris® valve is 30 to 200 mmH2O.
Three additional special pressure ranges are also available, to address specific clinical needs: 10 to
140 mmH2O (low pressure range), 50 to 300 mmH2O (High pressure range), and 80 to 400 mmH2O (very
high pressure range). Each Polaris® Valve is individually tested and identified by a unique serial number.
Pressure
range
1
3 Operating
pressure
16 mm
SPV-140 Polaris® Adjustable Valve, 10-140
5 operating pressure levels from 10 to 140 mmH2O:
1.8 mm
10, 40, 80, 110, 140 mmH2O.
No dot
Three dots
Polaris ®
Polaris® Adjustable Valves with Reservoir
7.2 mm
4.6 mm SPVA-300 Polaris® Adjustable Valve, 50-300,
Antechamber
5 operating pressure levels from 50 to 300 mmH2O:
51 mm 50, 100, 150, 220, 300 mmH2O. Integrated antechamber.
With Antechamber
SPVA-400 Polaris® Adjustable Valve, 80-400,
Antechamber
5 operating pressure levels from 80 to 400 mmH2O:
80, 150, 230, 330, 400 mmH2O. Integrated antechamber.
16 mm
16 mm
SPVB Polaris® Adjustable Valve, 30-200,
Burr-Hole Reservoir
5 operating pressure levels from 30 to 200 mmH2O:
30, 70, 110, 150, 200 mmH2O.
5 mm 4.6 mm Integrated Burr-Hole reservoir.
12 mm
With Burr-Hole Reservoir
12 mm
43 mm
Polaris ®
Polaris® Adjustable Valves with pre-connected SiphonX®
SiphonX® is a valve accessory designed to limit the siphon effect during cerebro-spinal fluid drainage.
It gives an additional resistance to the operating pressure of the valve depending upon the position
of the patient (maximum: + 200 mmH2O in the vertical position).
SPV-SX SPVA-SX
(with an Antechamber)
Polaris ®
Polaris® Adjustable Valve Kits
Polaris® Adjustable Valves are also available in kits, including a Polaris® valve, with 5 operating pressure
levels (from 30 to 200 mmH2O: 30, 70, 110, 150, 200 mmH2O), with or without reservoir, with a pre-attached
distal catheter (B905S) and separate ventricular catheter (BO19-10).
16 mm
SPV-2010 Polaris® SPV Kit B905S/BO19-10
110 cm
Right Angle Adapter on the ventricular catheter.
1,1 x 2,5 mm
23 cm
1,3 x 2,5 mm
13 mm
110 cm SPVA-2010 Polaris® SPVA Kit B905S/BO19-10
Integrated Antechamber.
1,1 x 2,5 mm Right Angle Adapter on the ventricular catheter.
23 cm
1,3 x 2,5 mm
With Antechamber
16 mm
110 cm
SPVB-2010 Polaris® SPVB Kit B905S/BO19-10
Integrated Burr-Hole Reservoir.
1,1 x 2,5 mm
23 cm
1,3 x 2,5 mm
Pressure 1
range
2
4
Operating
5 pressure
Two dots
7.2 mm
4.6 mm
51 mm
With Antechamber
4.6 mm
5 mm
12 mm With Burr-Hole
Reservoir
12 mm
43 mm
SM8B-2010 SM8-2010
SM8A-2010
23 cm
1.3 x 2.5 mm
16 mm
110 cm SM8-400-2010 Sophy® Mini SM8-400 Kit B905/BO19-10
8 operating pressure levels from 80 to 400 mmH2O.
1.1 x 2.5 mm
Right Angle Adapter on the ventricular catheter.
23 cm
1.3 x 2.5 mm
13 mm
110 cm
SM8A-2010 Sophy® Mini SM8A Kit B905S/BO19-10
1.1 x 2.5 mm Integrated Antechamber.
Right Angle Adapter on the ventricular catheter.
23 cm
1.3 x 2.5 mm
With Antechamber
16 mm
110 cm
SM8B-2010 Sophy® Mini SM8B Kit B905S/BO19-10
1.1 x 2.5 mm Integrated Burr-Hole Reservoir.
23 cm
1.3 x 2.5 mm
20 cm
0.8 mm
10 cm
1.5 x 3 mm
x
16 mm
110 cm
1.1 x 2.5 mm
20 cm
0.8 mm
63,5 cm
1.5 x 3 mm
x 16 mm
70 cm
1.1 x 2.5 mm
SM8-2040
13.8 mm
9 cm
SM1
16 mm
SM1-L Sophy® Mini Monopressure Valve,
One dot Low Pressure
Fixed operating pressure of 50 mmH2O.
1.8 mm
Two dots
SM1-M Sophy® Mini Monopressure Valve,
Medium Pressure
Fixed operating pressure of 110 mmH2O.
SM1-2010M SM1A-2010M
1.3 x 2.5 mm
SM1-2010H Sophy® Mini Monopressure
High Pressure Valve Kit B905S/BO19-10
Fixed operating pressure level of 170 mmH2O.
1.1 x 2.5 mm
SM1A-2010M Sophy® Mini Monopressure SM1A
Medium Pressure Valve Kit B905S/BO19-10
Fixed operating pressure level of 110 mmH2O.
23 cm Integrated antechamber.
1.3 x 2.5 mm
SM1A-2010H Sophy® Mini Monopressure SM1A
High Pressure Valve Kit B905S/BO19-10
Fixed operating pressure level of 170 mmH2O.
Integrated antechamber.
OPERATING PRINCIPLE
A tantalum weight ball presses on a ruby ball, which occludes the aperture of the passage of the CSF.
When SiphonX® is in the vertical position, the ruby ball is subjected to the full weight of the tantalum ball,
occludes the anti-siphon aperture, giving an additional resistance of 200 mmH2O to the operating pressure
of the valve.
When SiphonX® is in the horizontal position, the ruby ball is not subjected to the weight of the tantalum ball,
so does not occlude the aperture of the anti-siphon device.
In this horizontal position, the device is therefore open and does not add any additional resistance
to the operating pressure of the valve.
For all intermediate positions, SiphonX® adds a resistance which depends on the angle of inclination.
By design, SiphonX® is not affected by the implantation height relatively to cerebral ventricles.
200
Resistance (mmH2O)
150
100
50
Sx-200
Angle (°) 0 15 30 45 60 75 90
SiphonX® is available as an independant valve accessory, but also preattached to Polaris® valves (See page 8).
2.5 mm
5.9 mm
Standard Catheters
Available in different sizes for both children and adults, they are made of a transparent silicone elastomer, with
a radiopaque stripe entirely embedded within the silicone wall, and with a tantalum-labelled tip.
Markings indicate the depth of introduction into the cranial. All models are delivered with a right angle
adapter and an introducing stylet.
1.3 x 2.5 mm
16 mm
1.5 x 3 mm
23 mm
16 mm
1.3 x 2.2 mm
15 mm
Standard Catheters
Adult size
The Right Angle Ventricular Catheters, adult size, 1.5 mm ID (Internal Diameter), 3.0 mm OD (Outside
Diameter), with various intracranial lengths (x in cm) and with an extracranial length of 6 cm, are
multiperforated over a distance of 23 mm from the proximal tip. They are made of radiopaque silicone
elastomer and include an introducing stylet.
Product code Description
6 cm
23 mm
13 / 16 cm
0.8 mm
BO80 Right Angle Ventricular Catheter,
Adult, 8 cm
Intracranial length x = 8 cm.
Introducing stylet = 16 cm.
Anti-BlokTM Catheters
The Anti-Blok™ ventricular catheters are designed with four axial channels at the proximal tip, each with
recessed rectangular molded holes. The channels promote free CSF flow and discourage occlusion of the
holes by debris, tissue or choroid plexus.
Adult size
The Right Angle Ventricular Catheters, adult size, 1.5 mm ID (Internal Diameter), 3.0 mm OD (Outside
Diameter), with various intracranial lengths (x in cm) and with an extracranial length of 2 cm, are
multiperforated over a y distance (y in mm) from the proximal tip. They are made of radiopaque silicone
elastomer and include an introducing stylet.
x
SC06 Right Angle Anti-Blok™ Ventricular Catheter,
y
Adult, 6 cm
Intracranial length x = 6 cm. Proximal tip length y = 21 mm.
Introducing stylet = 13 cm.
K853362
22
HYDROCEPHALUS
Ventricular Catheters
Right-Angle Catheters
Standard Catheters
For cranial valve placement
Adult size
The Right Angle Ventricular Catheters with a reservoir, adult size, 1.5 mm ID (Internal Diameter), 3.0 mm
OD (Outside Diameter),, with various intracranial lengths (x in cm) and with an extracranial length of 2 cm,
are multiperforated over a distance of 23 mm from the proximal tip. They are made of radiopaque silicone
elastomer and include an introducing stylet. Reservoir allows CSF access and shunt testing.
20 cm
PRO9 Right Angle Ventricular Catheter,
Reservoir, 9 cm
0.8 mm
Intracranial length x = 9 cm. Introducing stylet = 20 cm.
Pediatric size
The right angle ventricular catheters with a reservoir, pediatric size, 1.1 mm ID (Internal Diameter), 2.2 mm
OD (Outside Diameter), with various intracranial x lengths (x in cm) and with an extracranial length of 2.3 cm,
are multiperforated over a distance of y (y in mm) from the proximal tip. They are made of radiopaque silicone
elastomer and include an introducing stylet. Reservoir allows CSF access and patency shunt testing.
A removable polysulfone plug is also provided. Removing this plug allows conversion of the ventriculostomy
catheter-reservoir into a shunt reservoir.
13,5 mm
13 cm
NNCR6 Right Angle Ventricular Catheter Reservoir,
0.9 mm
Venticular catheter introducing stylet Pediatric, 6 cm
Intracranial length x = 6 cm. Proximal tip length y = 20 mm.
Introducing stylet = 13 cm.
7.8 mm
2.2 mm
K853362
24
HYDROCEPHALUS
Ventricular Catheters
Right-Angle Catheters
Reservoir, 7 cm
Intracranial length x = 7 cm.
23 mm
20 mm
PLO8 Pectoral Ventricular Catheter,
Reservoir, 8 cm
20 cm Intracranial length x = 8 cm.
0.8 mm
PLO9 Pectoral Ventricular Catheter,
Reservoir, 9 cm
Intracranial length x = 9 cm.
K853362
26
HYDROCEPHALUS
Ventricular Catheters
Right-Angle Catheters with Reservoir
For cranial valve
placement with
endoscope
SRSxx
K853362
27
Distal Catheters
Atrial and Peritoneal
Sophysa atrial/peritoneal catheters are specifically designed for CSF drainage from the valve to the right
atrium of the heart, or to the peritoneal cavity.
15 cm
P06 Catheter, Peritoneal, Extension tube
1.2 mm ID, 2.5 mm OD, Length = 15 cm.
K853362 & K853371 CE0459 - Class III (only for B905S and B905S-20)
28
HYDROCEPHALUS
Catheter Set
Lumbo Peritoneal
The Sophysa Lumbo-Peritoneal Catheter Set is specificaly designed for CSF drainage from the
subarachnoid space of the spine to the peritoneal area.
LPS50
Bottom inlet
Burr-Hole type
RE-2010
13 mm
16 mm
23 cm
1.3 x 2.5 mm
16 mm
K013488
30
HYDROCEPHALUS
CSF Reservoirs I Standard
Flat Bottom
RE-2011
30 mm
RE-2011 Standard CSF Reservoir, Bottom inlet
Flat Bottom, 30 mm
Requires smaller trephine opening, compared
to the Burr-Hole model.
Transparent dome, base in polypropylene and radiopaque
concave bottom.
In case of needle penetration, the dome comes back
7 mm impervious after needle withdrawal.
4 suture holes.
8.5 mm
Access with a 24G or smaller Huber-needle.
4 mm
23 cm
1.3 x 2.5 mm
16 mm
K013488
31
CSF Reservoirs I Standard
Side-inlet
Side-Inlet CSF Reservoirs are flat-bottom reservoirs to be implanted away from the Burr-Hole made in the
skull.
RE-1021
RE-2021
1.3 x 2.5 mm
16 mm
30 mm
RE-2021 Standard CSF Reservoir, Side inlet,
2 mm Flat Bottom, 30 mm
6 mm Transparent dome, base in polypropylene and radiopaque
7 mm
bottom.
In case of needle penetration, the dome comes back
impervious after needle withdrawal
23 cm
4 suture holes.
1.3 x 2.5 mm Access with a 24G or smaller Huber-needle.
16 mm
K013488
32
HYDROCEPHALUS
CSF Reservoirs
Convertible
Convertible reservoirs are designed to be connected to a shunt, should this conversion become necessary.
For that purpose, they include a silicone lateral catheter closed at its distal end. This outlet catheter may be
cut and connected to a valve.
Burr-Hole type
RE-1030 RE-2030
16 mm
5 mm
RE-1030 Convertible CSF Reservoir, Burr-Hole,
2.2 mm 16 mm
20 mm
Transparent dome, base in polypropylene and silicone
12 mm closed-end catheter with a radiopaque stripe.
In case of needle penetration, the dome comes back
12 mm
impervious after needle withdrawal.
4 suture holes.
23 cm
Provided with a separated ventricular catheter.
Access with a 24G or smaller Huber-point needle.
1.3 x 2.5 mm
16 mm
6 mm 22 mm
RE-2030 Convertible CSF Reservoir, Burr-Hole,
2.2 mm 22 mm
20 mm Transparent dome, base in polypropylene and silicone
13 mm closed-end catheter with a radiopaque stripe.
In case of needle penetration, the dome comes back
impervious after needle withdrawal.
16 mm
4 suture holes.
Provided with a separated ventricular catheter.
23 cm
Access with a 24G or smaller Huber-point needle.
1.3 x 2.5 mm
16 mm
K013488
33
CSF Reservoirs I Convertible
Flat Bottom
RE-1031 RE-2031
7 mm 30 mm
RE-2031 Convertible CSF Reservoir,
2.2 mm
Flat Bottom, 30 mm
20 mm
Transparent dome, base in polypropylene, radiopaque
8.5 mm bottom and silicone closed-end catheter with a radiopaque
stripe.
In case of needle penetration, the dome comes back
4 mm
impervious after needle withdrawal.
4 suture holes.
23 cm Provided with a separated ventricular catheter.
Access with a 24G or smaller Huber-point needle.
1.3 x 2.5 mm
16 mm
K013488
34
HYDROCEPHALUS
CSF Reservoirs
Inline Shunt Reservoir
In-Line CSF Reservoirs incorporate an outlet catheter designed to be attached to a CSF shunt system.
The outlet catheter, 20 mm long, 1.1 mm ID (Internal Diameter), 2.2 mm OD (Outside Diameter), is made of
silicone elastomer with a radiopaque stripe.
All reservoirs are supplied with a separate ventricular catheter.
RE-1141
RE-1241
23 cm
1.3 x 2.5 mm
16 mm
20 mm
2 mm
RE-1241 In-Line CSF Reservoir, Double Dome,
20 mm
20 mm Side-inlet, flat bottom base.
7 mm Transparent dome, base in polypropylene and radiopaque
bottom.
In case of needle penetration, the dome comes back
6.7 mm
impervious after needle withdrawal.
2.2 mm 6 suture holes.
41 mm
Access with a 24G or smaller Huber-point needle.
23 cm
1.3 x 2.5 mm
K013488
35
Connectors
2-ways
Symmetrical
1.9 mm
Asymmetrical
CO-2010 CS2
K853369
38
HYDROCEPHALUS
Catheter Passers
Disposable
TUD-65
TUD-45
TUD-30
28 cm
4.1 x 5.3 mm
43 cm
4.1 x 5.3 mm
63 cm
CONTENTS
External CSF Drainage Systems 41
External CSF Drainage Catheters 43
External CSF Drainage Kits 45
40
EXTERNAL DRAINAGE
External CSF Drainage
Systems
Sophysa offers a complete range of External CSF Drainage and Monitoring Products. These allow aseptic
shunting of CSF from the ventricular cavities or lumbar subarachnoid spaces.
DE-210 model is a completely hermetic system, without vent, that allows aseptic shunting of CSF, from the
ventricular cavities or the lumbar subarachnoid spaces.
DE-210 DE-220
This device includes an integral drip chamber attached to the bag, without any vent, for decreased
contamination risks.
575 mm
DE-410 model is a complete CSF drainage system with a graduated drip chamber that allows CSF flow
rate calculation. This system also allows samples to be taken, medication to be injected and ICP to be
monitored.
DE-410 DE-420
This device includes a 100 ml graduated drip chamber allowing CSF flow rate calculation.
Ventricular catheters
Product Code Description
DE-104 External Ventricular Catheter (Medium Lumen)
Ventricular catheter in transparent silicone with a radiopaque
stripe:
2 x 3 mm
• 29 cm length, 2 mm ID, 3 mm OD, 1 mm diameter holes
• Multiperforated over a distance of 23 mm from the proximal tip
3.2 mm • Numerical markings from 3 to 28 cm from the proximal tip
Supplied with:
29 cm
• A female Luer-Lock connector
16 cm • Introducing stylet
• Trocar for tunnelling
• Suture tab
23 mm
3,6 mm
FVPC4 Ventricular catheter in radiopaque silicone elastomer:
• 35 cm length, 2.3 mm ID, 4 mm OD, 2 mm diameter holes
• Multiperforated over a distance of 23 mm from the proximal tip
• Depth markings at 5, 7.5, 10, 15 and 20 cm from the proximal tip
15 cm
35 cm
Supplied with:
• A female Luer-Lock connector
• Introducing stylet
• Trocar for tunnelling
• Pre-attached suture tab at 25 cm from the proximal end
23 mm
2mm
DE-109
Lumbar catheters
Product Code Description
90 cm
9 cm
DE-304 complete kit for External Drainage - Medium Lumen Ventricular Catheter
Complete kit for external ventricular drainage consists of :
- External Neurological Drainage System (DE-210)
- External Ventricular Catheter, Medium Lumen (DE-104)
DE-305 Complete Kit for External Drainage - Large Lumen Ventricular Catheter
Complete kit for external ventricular drainage consists of:
- External Neurological Drainage System (DE-210)
- External Ventricular Catheter, Large Lumen (DE-105)
DE-406 Complete Kit for External Ventricular Drainage and CSF Monitoring
Complete kit for external ventricular drainage and CSF monitoring consists of:
- External Drainage and CSF Monitoring System (DE-410)
- External Ventricular Catheter (DE-106)
DE-408 Complete Kit for External Lumbar Drainage and CSF Monitoring
Complete kit for external lumbar drainage and CSF monitoring consists of:
- External Drainage and CSF Monitoring System (DE-410)
- External Lumbar Catheter (DE-108)
CONTENTS
Pressio ® 2 Monitor 47
Pressio ® Catheters 48
Pressio ® Accessories 48
46
NEUROMONITORING
Neuromonitoring
Pressio® 2 Monitor
With the Pressio® 2 System, Sophysa offers a complete solution for the joint measurement of intracranial
pressure (ICP) and temperature (ICT). Pressio® 2 System consists of Pressio® 2 Monitor and dedicated
Pressio® Catheters. Pressio® 2 Monitor displays ICP and ICT measurements in real-time.
All clinical informations can be transferred directly to a patient monitor or to a computer.
Pressio® 2 Monitor
Product code Description
Pressio® accessories
Product code Description Product code Description
CONTENTS
Subcutaneous Access Ports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
49
Subcutaneous
Access Ports
SOPH-A-PORT® is a totally implantable device designed to provide repeated access to a selected body
site for both safety and comfort of the patient.
As a specialist in CSF, we offer a dedicated spinal access kit. Other access types are available such as
venous, peritoneal access in order to adapt the treatment to patients needs.
SOPH-A-PORT® access ports are characterized by their low profile design and reliable connection concept.
Height (mm) 13 10
50
SUBCUTANEOUS ACCESS PORTS
Spinal Access Ports
Spinal access kits include:
Spinal
Catheter
Tuohy
Needle
Standard or Mini
SOPH-A-PORT
Huber
Needle
51
Subcutaneous Access Ports
Other access ports systems can be selected: venous or peritoneal. Access ports are available in a Mini or
Standard model, catheter design is adapted to the specific needs of various implantation sites. Peritoneal
SOPH-A-PORT® is available in a preattached or unattached catheter configuration.
Venous and Peritoneal access ports kits include:
• One SOPH-A-PORT® access port (Mini or Standard)
• One catheter
• One Huber (straight) non-coring needle, 22 G
52
PRODUCT CODE INDEX
Product Code Index
Product code Page Product code Page Product code Page
53
Product Code Index
Product code Page Product code Page Product code Page
54
NOTES
Sophysa
5, rue Guy Moquet
91400 Orsay - France
Phone: +33 (0)1 69 35 35 00
Fax : +33 (0)1 69 35 36 90
Email: [email protected]
www.sophysa.com
Sophysa Benelux
Rue Emile Francqui 6
1435 Mont-Saint-Guilbert
Belgium
Phone: +32 (0)10 81 45 30
Email: [email protected]
www.sophysa.be