Ronda Medical
Integra LifeSciences

Codman® CERTAS™ Plus — Programmable valve for hydrocephalus

A programmable, implantable shunt valve for the management of hydrocephalus — non-invasive adjustment of the operating pressure across 8 settings (including "Virtual Off"), MRI-resistant up to 3 Tesla, available with the SiphonGuard® anti-siphon device and the Bactiseal® antimicrobial-impregnated catheter.

Codman® CERTAS™ Plus — the programmable valve with the Bactiseal® antimicrobial catheter (Integra material)
8Pressure settings
25–215 mmH₂OAdjustable range
3 TeslaMRI resistance
up to 50 daysBactiseal® protection
Clinical description

Codman® CERTAS™ Plus is a programmable, implantable shunt valve that provides a constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus. The operating pressure can be read and adjusted non-invasively, transcutaneously, over the course of the patient’s evolution — without further surgery — using the dedicated tool kits (Codman CERTAS® Tool Kit or CERTAS™ Plus Electronic Tool Kit).

The valve offers 8 pressure settings: 7 settings between 25 and 215 mmH₂O (25, 50, 80, 110, 145, 180, 215) to optimize drainage, plus the 8th "Virtual Off" setting, with a minimum operating pressure greater than 400 mmH₂O, which limits flow through the valve. The adjustable ruby bushing, ball & seat mechanism and the integrated reservoir are complemented by a tantalum ball coupled to a magnet, which allows the setting to be read on radiography as well (with the X-ray overlay tool). The valve is designed to resist unintended changes of the setting caused by external magnetic fields, including MRI up to 3 Tesla (confirmation of the setting after an MRI examination is recommended). Three housing models are available: Inline Regular (for most patients), Inline Small (low profile, with connectors oriented toward the skull to reduce local tissue tension), and Right Angle (for placement in the burr hole).

For additional control, the valve can be integrated with the SiphonGuard® anti-siphon device, which reduces the risk of overdrainage: at normal flow both pathways (primary and secondary) are open, and at excessive flow the primary pathway closes, the secondary remaining open to reduce the drainage rate. The rigid polyethersulfone housing makes it position-independent and unaffected by encapsulation or external pressure. To reduce the risk of infection, the system is also available with the Bactiseal® catheter — impregnated (not coated) with two slow-release antibiotics, rifampicin and clindamycin — which reduces gram-positive bacterial colonization of the catheter surface for up to 50 days. CERTAS™ Plus is the only Codman® programmable valve available with a unitized antimicrobial catheter.

Indications
  • Management of hydrocephalus — CSF drainage and maintenance of a constant intraventricular pressure (implantable shunt device).
  • Non-invasive adjustment of the operating pressure, according to the patient’s clinical course (8 settings).
  • Reduction of overdrainage risk — configuration with SiphonGuard®.
  • Reduction of gram-positive bacterial colonization of the catheter — configuration with Bactiseal®.
Key features

8 pressure settings

7 settings (25–215 mmH₂O) + the "Virtual Off" setting (>400 mmH₂O), for fine adjustment of drainage.

MRI-resistant up to 3 Tesla

Designed to resist unintended changes of the setting under external magnetic fields (confirm the setting after MRI).

3 housing models

Inline Regular, Inline Small (low profile), and Right Angle (burr hole) — for different anatomies and surgical preferences.

SiphonGuard® anti-siphon

Dual-pathway device (ball-spring) that reduces the risk of overdrainage, position-independent; integrated or stand-alone.

Bactiseal® antimicrobial catheter

Impregnated with rifampicin + clindamycin; reduces gram-positive colonization for up to 50 days (unitized — unique to Codman®).

Non-invasive adjustment

Transcutaneous reading and adjustment with the CERTAS® Tool Kit or Electronic Tool Kit; reading on radiography as well (X-ray overlay).

Precision mechanism

Ruby bushing, ball & seat, with an integrated reservoir and a tantalum-ball setting indicator.

Product gallery
Codman® CERTAS™ Plus — the programmable valve with the Bactiseal® antimicrobial catheter (Integra material)
Codman® CERTAS™ Plus — the programmable valve with the Bactiseal® antimicrobial catheter (Integra material)
Codman® CERTAS™ Plus — the three housing models: Inline Regular, Inline Small, and Right Angle (Integra material)
Codman® CERTAS™ Plus — the three housing models: Inline Regular, Inline Small, and Right Angle (Integra material)
Codman® CERTAS™ Plus Electronic Tool Kit — electronic kit for non-invasive adjustment of the pressure setting (Integra material)
Codman® CERTAS™ Plus Electronic Tool Kit — electronic kit for non-invasive adjustment of the pressure setting (Integra material)
Codman® CERTAS™ Plus — detail of the valve mechanism (ruby bushing, ball & seat, integrated reservoir, and SiphonGuard®), in a transparent housing (Integra material)
Codman® CERTAS™ Plus — detail of the valve mechanism (ruby bushing, ball & seat, integrated reservoir, and SiphonGuard®), in a transparent housing (Integra material)
Technical specifications
Type
Programmable, implantable shunt valve (adjustable differential pressure), for hydrocephalus
Pressure settings
7 settings — 25 / 50 / 80 / 110 / 145 / 180 / 215 mmH₂O + setting 8 "Virtual Off" (minimum pressure >400 mmH₂O)
Tolerances
Settings 1–3: ±20 mmH₂O; setting 4: ±25 mmH₂O; settings 5–7: ±35 mmH₂O (independent of gravitational orientation)
Mechanism
Adjustable ruby bushing, ball & seat mechanism; integrated reservoir; tantalum ball + magnet (setting indicator, radiographically readable)
MRI resistance
Up to 3 Tesla (confirmation of the setting after MRI examination is recommended)
Housing models
Inline Regular; Inline Small (low profile, connectors toward the skull); Right Angle (burr hole)
SiphonGuard® (optional)
Dual-pathway anti-siphon device (ball-spring), rigid polyethersulfone housing; position-independent; integrated or stand-alone
Bactiseal® (optional)
Catheter impregnated (not coated) with rifampicin + clindamycin; reduces gram-positive colonization for up to 50 days
Adjustment
Non-invasive — Codman CERTAS® Tool Kit or CERTAS™ Plus Electronic Tool Kit; reading on radiography as well (X-ray overlay)
Device class
I / IIb / III (MDD 93/42/EEC); CE marking
Legal manufacturer
Medos International SARL, Le Locle, Switzerland (Integra LifeSciences group)
Clinical evidence

A selection of publications and studies that mention use of the system. Summaries are indicative; for details, consult the original source.

Mode of Action of an Antimicrobial Biomaterial for Use in Hydrocephalus Shunts

Bayston R., Ashraf W., Bhundia C. · Journal of Antimicrobial Chemotherapy, 2004; 53(5):778–782

In vitro study of the Bactiseal® catheter impregnated with rifampicin and clindamycin, which evaluated the eradication of adherent gram-positive bacteria and the duration of antimicrobial protection on the catheter surface.

The impregnated catheter reduces gram-positive bacterial colonization for up to 50 days; complete eradication (100%) of adherent bacteria was achieved in less than 52 hours.
View source

Antibiotic or Silver Versus Standard Ventriculoperitoneal Shunts (BASICS): A Multicentre, Single-Blinded, Randomised Trial

Mallucci C.L., Jenkinson M.D., Conroy E.J. și colab. (BASICS Study Group) · The Lancet, 2019; 394(10208):1530–1539

Multicenter, randomized, single-blinded clinical trial with economic evaluation, which compared antibiotic-impregnated, silver-impregnated, and standard shunt catheters in patients with hydrocephalus (all age groups).

Antibiotic-impregnated catheters significantly reduced the shunt infection rate compared with standard ones, supporting their use to reduce shunt-associated infections.
View source

Cerebrospinal Fluid Shunt Infection in Patients With Antibiotic-Impregnated Catheters Versus Standard Shunts

Parker S.L., McGirt M.J. și colab. · Journal of Neurosurgery: Pediatrics, 2011; 8(3):259–265

Comparative study of the shunt infection rate between antibiotic-impregnated catheters and standard shunts, with analysis of the impact on total treatment costs.

Antibiotic-impregnated catheters were associated with a lower shunt infection rate and with a reduction in mean treatment costs per patient.
Certifications & compliance
CE marking (MDD 93/42/EEC) Class I / IIb / III MRI resistance up to 3 Tesla

Product code: Regular 828800–828807 · Small 828810–828817 · Right Angle 828820–828827 · Tool Kit 828851 / Electronic Tool Kit 828852

Device class: III (MDD 93/42/CEE)

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