About the THERAKOS™ CELLEX™ Photopheresis System
The THERAKOS™ CELLEX™ Photopheresis System
The THERAKOS™ CELLEX™ Photopheresis System is an integrated photopheresis system that is approved and CE marked specifically to perform photopheresis. The THERAKOS™ CELLEX™ Photopheresis System is designed to be used with the drug methoxsalen, and includes the THERAKOS™ CELLEX™ photopheresis instrument and the THERAKOS™ CELLEX™ procedural kit.
The THERAKOS™ CELLEX™ Photopheresis System is designed to separate a portion of the patient's blood and collect the white blood cell (WBC) fraction. The WBC fraction is then exposed to methoxsalen and ultraviolet-A (UVA) energy. The combination of methoxsalen and UVA light causes the WBCs to undergo apoptosis. Reinfusion of these WBCs into the patient can help modulate the patient’s immune system. This entire photopheresis process occurs in a closed blood circuit. This reduces the potential for infections and ensures that patients have their autologous cells returned to them.
Continuous flow technology
The THERAKOS™ CELLEX™ Photopheresis System is able to operate in single-needle or double-needle mode. The double-needle mode significantly reduces extra corporeal photopheresis (ECP) time because it enables continuous blood collection and return from and to the patient. However, if venous access is compromised or difficult to obtain, then the operator can also use CELLEX™ in discontinuous flow/single-needle mode, where blood collection and return are accomplished via the same site. If venous access fails during treatment, the system can easily be changed from double-needle to single-needle mode.
Advanced centrifuge design with continuous separation
The THERAKOS™ CELLEX™ advanced centrifuge design automatically isolates the leukocyte fraction in both flow modes (continuous or discontinuous). During continuous-flow separation, CELLEX™ maintains the expanding leukocyte fraction in the centrifuge, enabling single harvest collection. The constant spinning of the centrifuge allows separation, which results in highly efficient leukocyte collection and reduced treatment times.
Flexibility for individual patient needs
The THERAKOS™ CELLEX™ Photopheresis System provides flexibility and precision by combining automation with a simple manual override, which allows for customised collection via an active and informative operator interface.
The THERAKOS™ CELLEX™ Photopheresis System has the flexibility to manage individual patient needs related to blood volume and intravenous access. Flow rates can be adjusted to specific patient processed blood volume (within a range), and the user can effortlessly change from double-needle mode to single-needle mode.
Lower extracorporeal volume
The THERAKOS™ CELLEX™ Photopheresis System can operate safely and effectively using a lower extracorporeal and residual blood volume. The lower extracorporeal volume enables the treatment of patients sensitive to changes in extracorporeal volume, including paediatric patients and haemodynamically unstable patients. The lower residual blood volume (at the end of treatment) enables anaemic patients and patients with cardiac or pulmonary insufficiency to safely receive ECP.
Advanced single-harvest continuous-flow centrifuge
The CELLEX™ Photopheresis System includes a single-harvest, advanced, continuous-flow centrifuge. This ensures a consistent, single-harvest buffy coat, and maintains expanding leukocyte fraction in the centrifuge during continuous-flow separation. The CELLEX™ Photopheresis System will automatically isolate the leukocyte fraction using either continuous or discontinuous blood flow, and will collect in a single harvest.
It is also possible to achieve a more consistent buffy coat and reduce collection time, through Bowl Optic Sensor technology. The Bowl Optic Sensor automatically identifies the plasma/red blood cell (RBC) interface, and is used by the computer to establish the RBC pump speed and maintain the buffy coat within the spinning centrifuge bowl.
The THERAKOS™ CELLEX™ Photopheresis System has a highly interactive and informative customer interface that is easy to understand and control. This enables the operator to respond immediately to the patient’s needs. The interface is fully automated, but also has a manual override. The ability to manually override the photopheresis process allows for customised blood collection and, during buffy coat, the operator may expand the real-time haematocrit (HCT) chart to monitor automatic HCT detection or gain assistance with manual intervention.
The sophisticated, user-friendly CELLEX™ interface displays real-time ECP data in graphics and text; including processed blood volume, collect and return rates with corresponding line pressures, and fluid balance limits. The operator is able to direct all the treatment phases by adjusting 16 different parameter settings via the versatile touch screen keypad. The user is assisted by on-screen messages, which immediately display recommended corrective actions during warning alarm notifications.
A system specifically designed to perform photopheresis
All components of the THERAKOS™ CELLEX™ Photopheresis System have been validated to work together as an integrated system specifically for the purpose of performing photopheresis.25 THERAKOS™ CELLEX™ Photopheresis Systems are rigorously tested and have been demonstrated to provide safe and effective photopheresis treatments. The design and manufacturing processes for the THERAKOS™ CELLEX™ System are EU certified.25
Safe and effective photopheresis
An automatic haematocrit sensor in the CELLEX™ System determines when to stop buffy coat, and calculates photoactivation time. The system also automatically ensures that all treated leukocytes are returned to the patient following photoactivation.
When target volume of whole blood processed is reached, the concentrated leukocyte fraction (with minimal RBC contamination) is displaced out of the centrifuge.
Digital ultrasonic pulses are used to detect air bubbles in the patient return and collect lines, and the anticoagulant line. Additional air detectors are used to monitor the level of fluid in the Return Bag and the Treatment Bag.
The THERAKOS™ CELLEX™ Photopheresis Procedural Kit is also equipped with a custom Smart Card that logs function and treatment data. Each Smart Card is programmed with a unique number, and the information stored on the card can be used to help diagnose the system when service or technical assistance are required.