Haemonetics revealed it has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for its NexSys PCS plasma collection system with Persona PLUS technology.

Persona PLUS is the next generation of the company’s patented Persona technology, which tailors plasma collections to each donor. This helps improve average plasma volume per donation.

The FDA nod was supported by clinical data from a prospective, randomized, controlled, multicenter, pivotal trial involving over 30,000 plasma donations from almost 3,000 donors. It demonstrated the safety and effectiveness of the system, with results showing Persona PLUS delivered an average mid-single-digit increase of plasma per donation over the first generation 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 VP and chief commercial officer at Haemonetics.

According to the company, NexSys PCS is the industry’s most advanced, integrated system designed to streamline plasma collections and lower cost-per-liter through improved yield, productivity, safety, quality, compliance, and donor satisfaction.

Last month, Haemonetics announced the acquisition of Vivasure Medical, a Galway, Ireland-based company that develops next-gen technology for percutaneous vessel closure. Vivasure’s PerQseal Elite system uses a proprietary bioabsorbable patch to seal large-bore (up to 26F) arteriotomies and venotomies from inside the vessel. It offers a sutureless, fully absorbable solution for structural heart and endovascular procedures.