Development of next-generation Thrombelastographs

描述(由申请人提供)：Coramed正在商业化下一代护理点仪器TEG 6000系列，用于按需监测患者止血。该项目包括将技术从第二阶段完成的原型阶段转化为FDA批准和CLIA豁免的商业产品的活动。计划中的设备引入了一种全新的凝血监测技术--一种非常适合在从医院内到门诊诊所、医生办公室、救护车、战场以及最终患者家中的连续护理过程中使用的技术。一种无论设备位置或操作员都能产生及时和同等结果的设备，可以极大地提高有血栓倾向的患者的护理标准，并可以以更低的成本改善临床结果。TEG 6000系列设备是被广泛接受的血栓弹力仪(注册商标)(TEG(注册商标))TEG5000止血系统的继任者，该系统用于测量患者止血的所有阶段和状态，包括血栓前状态。然而，尽管TEG5000系统在临床和商业上取得了成功，但其配置排除了在医院内外的一些护理地点普遍使用的可能性。样本的大小和测试的复杂性要求人员能够进行静脉采血，能够进行吸管，并且接受过QC和其他实验室程序的培训。允许在医院以外的地方，如医生办公室使用这些设备，将使人们能够进行心脏病发作和中风风险的筛查，并监测抗凝和抗血小板治疗。要实现这一目标，需要紧凑且易于使用的仪器，如TEG 6000系列。 与公共健康相关：这笔赠款建议开发新的TEG 6000系列目前上市的血栓弹力仪(R)(TEG(R))止血系统(TEG 5000)。TEG 6000系列结合了一种新的方法来监控凝块形成和破裂过程中的粘弹性特性，适合在医院内外环境中使用，最终包括患者家中。这提供了在医生办公室、诊所、救护车、战场和其他患者接触地点筛查心脏病发作或中风风险的能力。在患者的护理点处监测凝血会带来更好的患者结果和更少的并发症。

DESCRIPTION (provided by applicant): Coramed is commercializing next-generation point of care instruments, the TEG 6000 series, for monitoring patient hemostasis on demand. This project includes activities to take the technology from the prototype stage completed in Phase II to FDA-cleared and CLIA-waived commercial products. The planned devices introduce a completely new technology for monitoring coagulation - one well suited for use across the continuum of care from inside the hospital to ambulatory care clinics, physician offices, ambulances, battlefields, and ultimately patient homes. A device that produces timely and equivalent results, regardless of device location or operator, can substantially enhance the standard of care for patients with a tendency to clot and can improve clinical outcomes at a reduced cost. The TEG 6000 series devices are successors to the widely accepted Thrombelastograph (R) (TEG(R)) TEG5000 Hemostasis System, which is used to measure all phases and states of patient hemostasis, including a prothrombotic state. However, despite the clinical and commercial success of the TEG5000 system, its configuration precludes general use in some point- of-care locations within and outside the hospital. The sample size and testing complexity require personnel who can perform phlebotomy, are able to pipette, and who are trained in QC and other lab procedures. Enabling use of these devices outside the hospital in sites such as physician offices will allow accessible screening for risk of heart attacks and stroke, and monitoring of anticoagulation and anti-platelet therapy. Achieving this goal requires compact and easy to use instruments such as the TEG 6000 series. PUBLIC HEALTH RELEVANCE: This grant proposes the development of a new TEG 6000 series of the currently marketed Thrombelastograph(R) (TEG(R)) Hemostasis System (TEG 5000). The TEG 6000 series incorporates a novel method for monitoring the viscoelastic properties of clots during formation and breakdown and is suitable for use in environments inside and outside the hospital, ultimately including patient homes. This provides the capability to screen for risk of heart attack or stroke in a physician's office, clinics, ambulances, battlefields and other point of patient contact locations. Monitoring blood coagulation at a patient's point of care results in better patient outcomes and fewer complications.