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FDA Clears the Individualized Nomogram for Rika Plasma Donation System

FDA Clears the Individualized Nomogram for Rika Plasma Donation System

The latest innovation is anticipated to increase collection volume without increasing collection time

  • Rika's individualized nomogram, iNomi, can enable plasma donors to donate the right amount of plasma on any given day based on height, weight and hematocrit.
  • The Rika Plasma Donation System (Rika) is designed for donor comfort and safety. On average, it completes plasma collections in 35 minutes or less, ensures there is never more than 200 milliliters of blood outside the donor's body at one time and has an advanced control system to guide device operators.
  • It can take 130 plasma donations to treat the annual needs of just one patient with a primary immune deficiency, according to the Plasma Protein Therapeutics Association.1

LAKEWOOD, Colo., May 9, 2024 /PRNewswire/ -- Terumo Blood and Cell Technologies (Terumo BCT), a medical technology company, recently received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Rika Plasma Donation System™ with the iNomi™ Nomogram. This innovation means that plasma collection volume can be determined by an individual donor's height, weight and hematocrit level on the day they donate plasma.

The Rika Plasma Donation SystemTM (Rika) is designed for donor comfort and safety. On average, it completes plasma collections in 35 minutes or less, ensures there is never more than 200 milliliters of blood outside the donor's body at one time and has an advanced control system to guide device operators.
The Rika Plasma Donation SystemTM (Rika) is designed for donor comfort and safety. On average, it completes plasma collections in 35 minutes or less, ensures there is never more than 200 milliliters of blood outside the donor's body at one time and has an advanced control system to guide device operators.

Terumo BCT makes a broad suite of medical devices that collect, separate and process blood and cells. Rika is the next-generation plasma collection system designed and developed for use in plasma collection centers.

"Terumo BCT continues to innovate for the plasma industry, setting new standards and expanding patient access to care," said Antoinette Gawin, President and Chief Executive Officer, Terumo Blood and Cell Technologies. "As the need for plasma increases, the Rika ecosystem, now including iNomi, is poised to help meet the demand while offering a potentially more comfortable and efficient experience for plasma donors."

The individualized nomogram is anticipated to increase collection volume without increasing collection time. The clinical trial to support the recent FDA clearance showed an average 10% increase in the volume of plasma collected per donation with an average collection time of less than 35 minutes.2

The Terumo BCT team behind Rika focused on technology and the experiences of plasma donors and collection center employees. A collection time of 35 minutes or less, combined with volume of 200 milliliters or less of blood outside the donor's body, can mean a more comfortable donation experience. Rika's advanced control system enhances donor safety by monitoring the process and providing alerts and visual cues that guide the operator. Rika makes automatic adjustments during each procedure, enabling a more seamless operator experience and the ability to spend more time with the donor.

"CSL Plasma looks forward to the rollout of the individualized nomogram as we continue to introduce the Rika Plasma Donation System to our close to 330 centers in the United States. We are eager to implement this latest innovation from Terumo that supports our dedication to our donors, employees and delivering on our promise to our patients," said Michelle Meyer, VP Plasma Global Operations, CSL Plasma.

Representing a new era in plasma collections, Rika was cleared for use by the FDA in March 2022 as part of an extensive ecosystem including the MyataTM Customer Service Portal and the KinariTM Device Management Platform, which enables electronic software distribution. All this is anticipated to support center productivity and efficiency to optimize plasma collections and meet the needs of patients affected by life-threatening illnesses who rely on plasma-derived therapies.

1.     https://www.pptaglobal.org/donate

2.     Clinical data available on file at Terumo Blood and Cell Technologies

About Terumo Blood and Cell Technologies Terumo Blood and Cell Technologies is a medical technology company. Our products, software and services enable customers to collect and prepare blood and cells to help treat challenging diseases and conditions. Our employees around the world believe in the potential of blood and cells to do even more for patients than they do today. This belief inspires our innovation and strengthens our collaboration with customers.

Terumo Blood and Cell Technologies' customers include blood centers, hospitals, therapeutic apheresis clinics, cell collection and processing organizations, researchers and private medical practices. Our customers are based in over 150 countries across the globe. We have 750+ granted patents, with more than 150 additionally pending.

We have global headquarters in Lakewood, Colo., U.S.A., along with five regional headquarters, seven manufacturing sites and six innovation and development centers across the globe. Terumo Blood and Cell Technologies is a subsidiary of Terumo Corporation (TSE: 4543), a global leader in medical technology.

 

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