Cerus Corporation has achieved a significant regulatory milestone with the CE mark approval of its next-generation LED-based illumination device, INT200, for the INTERCEPT Blood System. The approval, granted under the European Union Medical Device Regulation (MDR), enables the company to market its advanced pathogen inactivation technology throughout the EU and other regions that recognize CE marking.
The INT200 represents a substantial advancement in blood safety technology, building upon Cerus' established INTERCEPT Blood System platform for platelets and plasma. This approval follows the earlier CE mark certifications of INTERCEPT processing sets received in 2023, completing the system's authorization under the new EU MDR framework.
Enhanced Design and Operational Benefits
The next-generation illuminator incorporates significant improvements based on extensive customer feedback. "Taking into account feedback received from our customers, we designed the INT200 to provide a significantly improved user experience and operational benefits through enhanced physical design and a novel software interface," explained Vivek Jayaraman, Cerus' Chief Operating Officer.
Key features of the INT200 include:
- Compatibility with existing disposable processing sets
- Maintained pathogen inactivation process efficiency
- Enhanced physical design for improved usability
- New software interface for better operational control
Strategic Commercial Impact
The CE mark approval represents more than just a regulatory achievement; it positions Cerus for significant market expansion. "We believe the INT200 will be the foundational platform for geographic expansion and future growth of the INTERCEPT business," stated Obi Greenman, President and CEO of Cerus Corporation.
The company plans to support existing customers in their transition to the new device while simultaneously expanding into new markets. This strategic approach aligns with Cerus' mission to safeguard the global blood supply through innovative pathogen reduction technologies.
Implementation and Future Developments
While the CE mark represents the first regulatory approval for the INT200, Cerus has outlined plans for additional regulatory submissions in the coming years. The company intends to utilize the INT200 platform for future innovations in platelet and plasma systems, demonstrating its commitment to advancing blood safety technology.
Blood centers transitioning to the new system can expect a robust and reliable pathogen inactivation platform that maintains the high standards they have come to expect from Cerus. The implementation process will be gradually rolled out over the next few years, ensuring smooth integration into existing blood banking operations.
