The 510(k) clearance was supported by clinical data from a prospective, randomized, controlled, multicenter, pivotal trial involving over 30,000 plasma donations from nearly 3,000 donors, demonstrating the safety and effectiveness of the NexSys PCS Plasma Collection System with Persona PLUS technology. Trial results showed Persona PLUS delivered on average a mid-single digit percent increase of plasma per donation over Persona.
“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,” said Roy Galvin, Executive Vice President and Chief Commercial Officer at Haemonetics.
Haemonetics is the global leader in the plasma collections market. NexSys PCS is the industry’s most advanced, completely integrated system designed to streamline plasma collections and lower cost-per-liter through improved yield, productivity, safety, quality, compliance and donor satisfaction.