Development of next-generation Thrombelastographs

描述（由申请人提供）：Coramed正在商业化下一代床旁监护仪器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用于监测凝血的全新技术-一种非常适合从医院内部到门诊护理诊所，医生办公室，救护车，战场以及最终患者家中的连续护理中使用的技术。无论器械位置或操作者如何，器械均能产生及时且等效的结果，可显著提高有凝血倾向患者的护理标准，并能以较低的成本改善临床结局。TEG 6000系列设备是广泛接受的血栓弹力仪（R）（TEG（R））TEG 5000止血系统的后继产品，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TEG 5000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床旁位置的一般使用。样本量和测试复杂性要求人员能够执行静脉切开术，能够移液，并接受过QC和其他实验室程序的培训。在医院外的医生办公室等场所使用这些设备将允许对心脏病发作和中风风险进行无障碍筛查，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。

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.