FDA Clears the Individualized Nomogram for Rika Plasma Donation System
Terumo Blood and Cell Technologies (Terumo BCT) received FDA clearance for the Rika Plasma Donation System with the iNomi Nomogram, a new innovation that allows plasma donors to donate the right amount of plasma based on their individual characteristics. This system aims to increase collection volume without extending collection time, with an average 10% increase in plasma volume collected per donation in less than 35 minutes. Rika is designed for donor comfort and safety, ensuring a seamless and efficient experience for plasma donors and collection center employees. This innovation is expected to enhance patient access to care and support the needs of patients relying on plasma-derived therapies.
The FDA clearance for the Rika Plasma Donation System with the iNomi Nomogram opens up new possibilities for increased plasma collection volume without extending collection time, addressing the growing need for plasma and expanding patient access to care.
The average 10% increase in plasma volume collected per donation in less than 35 minutes demonstrates the efficiency and effectiveness of the Rika Plasma Donation System, providing a more comfortable experience for donors and enhancing donor safety.
While the Rika Plasma Donation System with the iNomi Nomogram offers benefits such as increased plasma collection volume and donor comfort, there may be potential challenges in the implementation and adoption of this new system in plasma collection centers, which could impact the overall effectiveness and efficiency of the process.
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
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
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
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.
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
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SOURCE Terumo Blood and Cell Technologies
FAQ
What is the Rika Plasma Donation System?
The Rika Plasma Donation System is a new innovation from Terumo Blood and Cell Technologies that allows plasma donors to donate the right amount of plasma based on their individual characteristics, aiming to increase collection volume without extending collection time.
What is the iNomi Nomogram?
The iNomi Nomogram is a feature of the Rika Plasma Donation System that enables plasma donors to donate the right amount of plasma on any given day based on their height, weight, and hematocrit level.
What is the average collection time for the Rika Plasma Donation System?
The Rika Plasma Donation System completes plasma collections in 35 minutes or less, ensuring donor comfort and safety with advanced control systems and a volume of 200 milliliters or less of blood outside the donor's body at one time.
What is the FDA clearance for the Rika Plasma Donation System?
The FDA recently cleared the Rika Plasma Donation System with the iNomi Nomogram, allowing plasma collection volume to be determined by an individual donor's height, weight, and hematocrit level on the day of donation.
What is the impact of the Rika Plasma Donation System on plasma donations?
The Rika Plasma Donation System is anticipated to increase collection volume without increasing collection time, with an average 10% increase in the volume of plasma collected per donation in less than 35 minutes, offering a more comfortable and efficient experience for plasma donors.
