Haemonetics (NYSE:HAE) announced that it received FDA 510(k) clearance for its NexSys PCS system with Persona technology.
Boston-based Haemonetics’ new, proprietary Persona technology customizes plasma collection based on an individual donor’s body composition, according to a news release.
NexSys PCS (plasma collection system) with Persona is intended for use as an automated cell separator system and blood component collector with single-use, sterile, disposable sets, with or without saline compensation.
Clearance came on the back of clinical data from the Impact study of 3,443 donors who underwent 23,137 plasma donations. Using NexSys PCS with Persona, results shoed an average 8.2% increase in volume of plasma collected per donation when compared with NexSys PCS with YES technology.
“The NexSys PCS system has transformed and improved the way our customers can collect plasma,” Haemonetics president & CEO Chris Simon said in the release. “Persona builds on that legacy by delivering meaningful innovation and reinforces our commitment to supporting the plasma industry.”