Improved plasma removal efficiency for therapeutic plasma exchange using a new apheresis platform

Area of Science:

• Medical Devices
• Apheresis Technology
• Clinical Trials

Background:

• The Spectra Optia (SPO) is a novel apheresis device built upon the COBE Spectra (CSP) platform.
• This study aimed to compare the safety and efficiency of the SPO against its predecessor, the CSP.

Purpose of the Study:

• To evaluate the performance of the Spectra Optia (SPO) apheresis device.
• To compare the SPO's safety and efficiency against the predicate COBE Spectra (CSP) device.

Main Methods:

• A randomized, nonblinded, paired (crossover) clinical trial involving twenty patients.
• Primary outcome: plasma removal efficiency (PRE). Secondary outcomes: platelet content, hemolysis, cellular counts, coagulation/complement activation, fluid balance accuracy, and adverse events.

Main Results:

• Spectra Optia (SPO) achieved 87% PRE with 1.0% platelet loss, significantly better than CSP (79% PRE, 3.0% PLT loss).
• Machine fluid balance accuracy exceeded 97%, with fluid balance within 2% of measured values.
• No significant changes in patient cellular counts, coagulation activation, or complement cascade activation were observed with either device. No significant adverse events were reported.

Conclusions:

• The Spectra Optia (SPO) demonstrates superior performance characteristics compared to the COBE Spectra (CSP).
• The SPO is deemed acceptable for use in therapeutic plasma exchange programs based on its improved safety and efficiency profile.