FDA Approves Rika System, a Novel Plasma Collection Device

FDA Approves Rika System, a Novel Plasma Collection Device

The US Food and Drug Administration has approved a novel plasma collection device designed to meet the rapidly increasing demand for human plasma-based therapies.

The Rika system, a next-generation automated technology developed jointly by Terumo Blood and Cell Technologies and CSL Plasma, ensures that no more than 200 mL of blood is outside the donor’s body at any given time, and reduces collection time by 30% — to about 35 minutes or less — compared with existing technology averages, the companies report.

Plasma-based therapies, which are currently used for approximately 1500 indications, have been designated by the World Health Organization as essential medicines. Further, the Plasma Protein Therapeutics Association notes that it can take 130 plasma donations to meet the annual needs of just one patient with a primary immune deficiency, and about 1200 for a patient with hemophilia.

The Rika system speeds the process for meeting these needs and is designed to improve safety and donor comfort, the companies state in a press release announcing the FDA approval.

A limited market release of the system at CSL Plasma collection centers is planned for this spring, followed later in the year by full US rollout.

Sharon Worcester is an award-winning medical journalist at MDedge News, part of the Medscape Professional Network.

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