FDA clears Haemonetics’ NexSys PCS With Persona Technology

5 October 2020 (Last Updated October 12th, 2020 16:51)

Haemonetics has received US Food and Drug Administration (FDA) 510(k) clearance for its NexSys PCS system with Persona technology.

Haemonetics has received US Food and Drug Administration (FDA) 510(k) clearance for its NexSys PCS system with Persona technology.

The proprietary technology is the latest enhancement of the NexSys PCS system. It customises plasma collection based on the body composition of the individual donor.

It is intended for use as an automated cell separator system and blood component collector in, together with single-use sterile disposable sets with or without saline compensation.

Haemonetics president and CEO Chris Simon said: “The NexSys PCS system has transformed and improved the way our customers can collect plasma.

“Persona builds on that legacy by delivering meaningful innovation and reinforces our commitment to supporting the plasma industry.”

The system was cleared by the FDA based on clinical data from the IMPACT study, which evaluated the safety and effectiveness of the device.

Claimed to be one of the largest clinical trials on the topic of plasmapheresis, this multicentre, prospective, double-blinded, randomised controlled clinical trial enrolled 3,443 donors who underwent 23,137 plasma donations.

Haemonetics Medical Affairs, Clinical Development and Medical Safety vice-president Dr Jan Hartmann said: “Plasma is an essential component used to make life-saving and life-improving medicines for many conditions, and the current nomogram has been a safe and effective method for collecting plasma for decades.

“Persona now sets a new paradigm by leveraging improved technology and taking a personalised approach to optimise plasma collection for each individual donor.”

According to the data by the Plasma Protein Therapeutics Association (PPTA), around 750,000 people across Europe and North America depend on plasma for life-saving therapies.

Plasma-derived medicines are used for the treatment of several conditions, including primary immunodeficiency, hemophilia and others. Hundreds of plasma donations are required to treat a single patient.