Description

The KIT EXCHANGE SPECTRA OPTIA is a specialized disposable kit crafted by Terumo BCT for seamless integration with the Spectra Optia Apheresis System. This kit is engineered to support a variety of exchange therapy protocols, making it an essential tool in clinical settings for qualified medical personnel.

Key Features

• Versatile Procedure Support: The kit facilitates multiple procedures including Therapeutic Plasma Exchange (TPE), TPE with a secondary plasma device, TPE with single-needle access, and Red Blood Cell Exchange (RBCX).
• High Plasma Removal Efficiency: Achieves a mean plasma removal efficiency of 87%, with most outcomes ranging between 80% and 91%.
• Low Platelet Loss: Maintains platelet loss typically between 0.3% and 1.6%, ensuring minimal impact on patient platelet levels.

Operational Details

• Procedure Time: Varies from 55 to 135 minutes, influenced by protocol specifics and patient factors.
• Anticoagulant Management: Utilizes ACD-A with precise infusion ratios, enhancing safety and efficiency.
• Whole Blood Processing: Handles 5,555 to 6,796 mL per procedure with an extracorporeal volume typically around 141 mL.

System Integration

• Setup and Accuracy: Approximately 15-minute setup time with pump accuracy of at least 97%, optimizing fluid balance.
• Access Flexibility: Offers dual-needle and single-needle access, accommodating various patient needs.
• User Interface: Features graphical interfaces for intuitive management and automated interface management for optimal plasma separation.

Clinical Applications

The kit is indicated for a broad spectrum of conditions, including neurological disorders like myasthenia gravis and Guillain-Barré syndrome, hematological conditions such as thrombotic thrombocytopenic purpura, and renal challenges like ABO-incompatible kidney transplantation. It shows no known contraindications beyond those common to all automated apheresis systems.

Safety and Performance

• Adverse Events: Mild citrate toxicity occurs in a small percentage of cases, with no serious adverse events reported.
• Comparative Performance: Demonstrates superior plasma removal efficiency, reduced platelet loss, and faster procedure times compared to previous systems, enhancing overall patient safety.

Usage Guidelines

This product is restricted to prescription use and should be operated by medical personnel familiar with the system’s instructions. Availability of specific products and protocols may vary by country, necessitating awareness of local regulations.