Haemonetics Achieves FDA Clearance for Advanced Plasma Collection System NexSys® PCS with Innovative Technology

Haemonetics' Latest Advancement: FDA Clearance for NexSys® PCS Plasma Collection System

In a significant move for the medical technology sector, Haemonetics Corporation, a leader in blood management and plasma collection services, has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its innovative NexSys PCS® Plasma Collection System equipped with the cutting-edge Persona® PLUS technology. This authorization opens the pathway for enhanced plasma collection methods that cater specifically to the needs of individual donors, ultimately aiming to raise plasma yields with each donation.

Understanding NexSys PCS and Persona PLUS Technology

The NexSys PCS Plasma Collection System marks a new chapter in Haemonetics' legacy of innovation. The Persona PLUS technology, which is a proprietary and patented solution, optimizes plasma collection by customizing the process to the unique profiles of donors. With this personalization, the system facilitates a notable increase in the volume of plasma collected per donation, addressing the growing demands of plasma-derived therapies.

The FDA's approval was bolstered by robust clinical data gathered from a pivotal trial that involved over 30,000 plasma donations from nearly 3,000 donors. This extensive, randomized, and controlled study corroborated that the NexSys PCS with Persona PLUS not only meets safety and effectiveness standards but also provides an average uptick in plasma volume collected per donation.

The Demand for Innovation in Plasma Collection

Roy Galvin, Executive Vice President and Chief Commercial Officer of Haemonetics, emphasized the necessity for innovation in plasma collection technologies as the demand for plasma-derived therapies surges. “Plasma centers face an increasing need for solutions that not only enhance operational efficiency but also do so in a cost-effective manner,” Galvin commented. He believes that Persona PLUS will significantly lower cost-per-liter metrics while enhancing yields safely and effectively.

The NexSys PCS is recognized as an industry leader in plasma collection technology. This comprehensive, integrated system is designed with several enhancements to streamline operations, boost productivity, and ensure the safety and satisfaction of donors during the collection process. Haemonetics is steadfast in its commitment to offer advanced technologies that fundamentally improve the quality of care and operational efficiency within healthcare.

Commitment to Transforming Health Care

Haemonetics is more than just a technology provider; it is a vital player in enhancing healthcare standards. The company is devoted to addressing pressing medical needs through a spectrum of thoughtful innovations. With an entire suite of hospital technologies and optimized plasma collection processes, Haemonetics strives to make significant improvements in patient outcomes, thereby raising the standards of care in medical settings.

Additionally, the company offers products designed to assist blood centers in efficiently collecting essential blood components, further supporting the healthcare ecosystem.

Looking Ahead: The Future of Plasma Collection

With the FDA clearance now in hand, the focus shifts towards implementing this advanced technology across various plasma collection centers. As the landscape of medical technology evolves, innovations like the NexSys PCS with Persona PLUS will likely play a pivotal role in shaping the future of donor experiences and plasma collection methodologies. By prioritizing safety, efficiency, and personalized care, Haemonetics is paving the way for success in addressing the growing global demand for high-quality plasma.

As the world anticipates the adoption of such an innovative system, Haemonetics affirms its commitment to contribute positively to the healthcare industry, ensuring that they continue to meet evolving medical needs with pioneering solutions. Stay updated on their progress and find more information about their technologies by visiting Haemonetics' official website.