THERAKOS™ CELLEX™ Photopheresis System

The CELLEX™ System delivers operational efficiency and helps minimise treatment time*¹

• Higher cell collection efficiency (mean proportion of WBCs from blood processed): CELLEX™ System 34.2% vs multistep procedure 21.0% (+13.2%, p<0.001)
• Shorter treatment times (mean): CELLEX™ System 99.27 minutes vs multistep procedure 122.03 minutes (+22.76, p<0.05)

Reassurance for physicians and operators, comfort for the patient

• Flexibility to switch between single- or double-needle modes at any time during the procedure^2,3
• Because your patient remains connected throughout the procedure:^4,5
  • Minimised reinfusion errors⁴and risk of cross-contamination^4,5
  • Minimal risk of microbial contamination^4,5
    

• Five peristaltic pumps move fluids by the action of multiple equally spaced rollers, which rotate and compress a flexible tube⁶

*Retrospective, observational, comparative study of 30 treatment pairs performed on two consecutive days in 15 patients¹

†The apheresis device used in the multistep procedure in the study was Spectra OPTIA apheresis system and MacoGenic G2.¹

1. Mayer W, et al. J Clin Apher. 2022;37(4):332-339. 2. Bisaccia E, et al. Br J Dermatol. 2009;161(1):167-169. 3. Data on file - Ref-08335. Therakos LLC. 4. Knobler R, et al. J Eur Acad Dermatol Venereol. 2020;34(12):2693-2716. 5. Perotti C, Sniecinski I. Transfus Apher Sci. 2015;52(3):360-368. 6. Operator’s Manual. THERAKOS™ CELLEX™ Photopheresis System. For Use with Software 5.6. Therakos. 2024.

CELLEX™ System provides the versatility to treat a wide range of patient types

Vascular access¹

Choice of single- or double-needle mode and ability to switch between the two according to venous access conditions

No lower limit for leukocyte levels¹

Continuous collection and separation enables treatment even with low leukocyte levels

Different disease states¹

Spectrum of white blood cells is collected, making treatment applicable to MDR-approved disease states

Choice of anticoagulant¹

Choice between Anticoagulant Citrate Dextrose Solution A (ACD-A) and heparinised saline solution according to patient profile

Haemodynamic instability and low body weight^1,2

Blood priming and minimised extracorporeal volume enable treatment

Abnormal lipid and bilirubin in plasma¹

Bowl optic sensor allows customisation of the system to the needs of abnormal plasma conditions

Adjustable to cardiac, pulmonary or renal function¹

Double-needle mode minimises fluid shifts

ECP, extracorporeal photopheresis; MDR, Medical Device Regulation.

1. Operator’s Manual. THERAKOS™ CELLEX™ Photopheresis System. For Use with Software 5.6. Therakos. 2024. 2. Bisaccia E, et al. Br J Dermatol. 2009;161(1):167-169.

The CELLEX™ System automatically manages treatment

Automated 8-MOP dosage calculation¹

Helps minimise dosage errors

Specific algorithm for consistent UVA irradiation¹

Photoactivation time automatically calculated and set according to remaining lamp lifetime, percentage of haematocrit and treatment volume

Minimised workflow complexity¹

No need for operators to move the treatment bag between separate devices for apheresis and photoactivation

8-MOP, 8-methoxypsoralen; UVA, ultraviolet A.

1. Operator’s Manual. THERAKOS™ CELLEX™ Photopheresis System. For Use with Software 5.6. Therakos. 2024

The CELLEX™ System automatically controls collection

Bowl optic sensor automatically identifies the red cell layer¹

• Allows automated adaptation to the patient’s plasma conditions
• Delivers a consistent buffy coat

Haematocrit sensor provides automated detection of haematocrit¹

• Automatically determines when buffy coat collection should end
• Final data automatically informs photoactivation time

Automated flow rate controls¹  reduces the need for operator interventions

1. Operator’s Manual. THERAKOS™ CELLEX™ Photopheresis System. For Use with Software 5.6. Therakos. 2024.

Key features of the CELLEX^TM System¹

• One kit (single/double needle) for all procedures
• Single uninterrupted sterile fluid path
• Automated flow rate controls minimises the need for operator intervention
• One technology interface – integrated touchscreen
• One kit (single/double needle) for all procedures
• Compact mobile system that can be moved between departments*

*Contact your Therakos representative if you intend to move the CELLEX™ device within your unit.

1. Operator’s Manual.THERAKOS™ CELLEX™ Photopheresis System. For Use with Software 5.6. Therakos. 2024.

All-in-one, fully integrated & MDR-approved

Treat patients with MDR-approved technology 

MDR approved¹

The THERAKOS™ CELLEX™ Photopheresis System has obtained CE Certification under the Medical Device Regulation (EU MDR) 2017/745

MDR: Ensuring device safety and efficacy in approved indications

Restriction of Hazardous

Substances Directive (RoHS)^2,3

New RoHS3 directive-compliant CELLEX™ Procedural Kit, which complies with the latest RoHS Standard (new CLXSP-I kit). These kits are available when machines are upgraded to the latest compatible software

ISO 13485:2016 & EN ISO 13485:2016 certified*⁵

Therakos Quality Management System certified for the design, manufacture, distribution and service of Photopheresis Systems

EC Declaration of Conformity

Medical Device Regulation (EU MDR) 2017/7452

• Can be used safely with the materials, substances and gases with which they enter into contact

*Certified by a Notified Body (BSI Certificate of Registration number MD 665632).⁵

BSI, British Standards Institution; CE, Conformité Européene; EC, European Council; EU, European Union; ISO, International Organization for Standardization.

1. Data on file - Ref-07582. Therakos LLC. 2. Operator’s Manual. THERAKOS™ CELLEX™ Photopheresis System. For Use with Software 5.6. Therakos. 2024. 3. Data on file - Ref-07074. Therakos LLC. 4. Data on File - ref-08366. Therakos (UK) LLC.