EN
登录

医疗设备研发商Terumo BCT Rika血浆捐献系统™获得FDA 510(k)批准

FDA Clears the Individualized Nomogram for Rika Plasma Donation System

CISION 等信源发布 2024-05-09 20:00

可切换为仅中文


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

预计最新的创新将在不增加收集时间的情况下增加收集量

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.

Rika的个性化列线图iNomi可以使血浆捐献者根据身高,体重和血细胞比容在任何一天捐赠适量的血浆。

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..

Rika血浆捐赠系统(Rika)旨在为捐赠者提供舒适和安全。平均而言,它在35分钟或更短的时间内完成血浆采集,确保捐献者身体外的血液一次不超过200毫升,并拥有先进的控制系统来指导设备操作员。。

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

据血浆蛋白治疗协会(plasma Protein Therapeutics Association)称,仅一名原发性免疫缺陷患者的年度需求就需要130份血浆捐赠。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..

科罗拉多州莱克伍德,2024年5月9日/PRNewswire/--医疗技术公司Terumo Blood and Cell Technologies(Terumo BCT)最近获得了美国食品和药物管理局(FDA)510(k)对Rika Plasma捐赠系统™和iNomi™列线图的许可。这项创新意味着血浆采集量可以通过捐献者捐赠血浆当天的身高,体重和血细胞比容水平来确定。。

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..

Rika血浆捐赠系统TM(Rika)旨在为捐赠者提供舒适和安全。平均而言,它在35分钟或更短的时间内完成血浆采集,确保捐献者身体外的血液一次不超过200毫升,并拥有先进的控制系统来指导设备操作员。。

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制造了一套广泛的医疗设备,用于收集、分离和处理血液和细胞。Rika是为血浆采集中心设计和开发的下一代血浆采集系统。

'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.'.

Terumo Blood and Cell Technologies总裁兼首席执行官安托瓦内特·加温(AntoinetteGawin)说,Terumo BCT继续为血浆行业创新,制定新标准,扩大患者获得护理的机会随着对血浆需求的增加,Rika生态系统(现在包括iNomi)准备帮助满足需求,同时为血浆捐献者提供可能更舒适和有效的体验。”。

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.2The Terumo BCT team behind Rika focused on technology and the experiences of plasma donors and collection center employees.

预计个性化列线图将在不增加采集时间的情况下增加采集量。支持最近FDA批准的临床试验显示,每次捐赠的血浆量平均增加10%,平均收集时间不到35分钟。2 Rika背后的Terumo BCT团队专注于技术和血浆捐赠者的经验和收集中心员工。

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.

35分钟或更少的采集时间,加上捐献者身体外200毫升或更少的血液,可能意味着更舒适的捐赠体验。Rika的先进控制系统通过监测过程并提供警报和视觉提示来指导操作员,从而提高了捐赠者的安全性。

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.

Rika在每次手术过程中都会进行自动调整,使操作者体验更加无缝,并能够与捐赠者度过更多时间。”CSL Plasma期待着个性化列线图的推出,因为我们将继续向美国近330个中心推出Rika血浆捐赠系统。

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.

CSL Plasma Plasma全球运营副总裁米歇尔·梅耶(MichelleMeyer)说,我们渴望实施Terumo的这项最新创新,以支持我们对捐赠者、员工的奉献,并兑现我们对患者的承诺。Rika代表了血浆采集的新时代,于2022年3月被FDA批准使用,作为包括MyataTM客户服务门户和KinariTM设备管理平台在内的广泛生态系统的一部分,该平台支持电子软件分发。

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..

预计所有这些都将支持中心的生产力和效率,以优化血浆采集,并满足依赖血浆衍生疗法的威胁生命的疾病患者的需求。。

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

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

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

2.Terumo Blood and Cell Technologies存档的临床数据

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.

关于Terumo Blood and Cell Technologies Terumo Blood and Cell Technologies是一家医疗技术公司。我们的产品、软件和服务使客户能够收集和准备血液和细胞,以帮助治疗具有挑战性的疾病和病症。我们在世界各地的员工相信,血液和细胞的潜力比今天对患者的贡献更大。

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.

这种信念激发了我们的创新,加强了我们与客户的合作。Terumo Blood and Cell Technologies的客户包括血液中心、医院、治疗性单采诊所、细胞采集和处理组织、研究人员和私人医疗机构。我们的客户遍布全球150多个国家。

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.SOURCE Terumo Blood and Cell Technologies.

我们拥有750多项授权专利,另有150多项正在申请中。我们在美国科罗拉多州莱克伍德拥有全球总部,在全球拥有五个地区总部、七个制造基地和六个创新与发展中心。Terumo Blood and Cell Technologies是全球医疗技术领导者Terumo Corporation(TSE:4543)的子公司。来源Terumo Blood and Cell Technologies。