The NexSys PCS system with Persona PLUS technology demonstrated mid-single digit percent increase in plasma volume per donation in pivotal trial.
The Food and Drug Administration (FDA) has granted 510(k) clearance to Haemonetics Corp for its NexSys PCS Plasma Collection System with Persona PLUS technology, marking the next generation of the company’s donor-tailored plasma collection platform.
The clearance was supported by clinical data from a prospective, randomized, controlled, multicenter pivotal trial involving more than 30,000 plasma donations from nearly 3,000 donors. Trial results showed Persona PLUS delivered on average a mid-single digit percent increase of plasma per donation compared to the previous Persona technology.
Persona PLUS represents an advancement of Haemonetics’ proprietary and patented Persona technology that customizes plasma collections to each individual donor to improve average plasma volume per donation.
“With the growing demand for plasma-derived therapies, plasma collectors’ need for innovation to scale operations efficiently and cost-effectively has never been greater. Persona PLUS extends Haemonetics’ leadership in delivering solutions which lower cost-per-liter and enhance yields safely,” says Roy Galvin, executive vice president and chief commercial officer at Haemonetics, in a release.
Industry’s Most Advanced Integrated System
The NexSys PCS is designed as a completely integrated system to streamline plasma collections and reduce cost-per-liter through improved yield, productivity, safety, quality, compliance and donor satisfaction. Haemonetics positions itself as the global leader in the plasma collections market.
The enhanced Persona PLUS technology builds on the existing platform’s ability to tailor collection parameters to individual donor characteristics, with the clinical trial data demonstrating measurable improvements in plasma yield per donation session.
The 510(k) clearance pathway requires manufacturers to demonstrate that their device is substantially equivalent to legally marketed predicate devices in terms of safety and effectiveness. The extensive clinical trial data package supported the FDA’s determination that the enhanced system meets these regulatory standards.
Plasma collection efficiency remains a critical factor for plasma centers as demand for plasma-derived therapies continues to increase globally. Technologies that can safely increase yield per donation help centers optimize operations while maintaining donor safety and satisfaction.
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