Development of next-generation Thrombelastographs
Department of Health and Human Services
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Small Business Information
6225 W HOWARD ST, NILES, IL, -
Socially and Economically Disadvantaged:
AbstractDESCRIPTION (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 careclinics, 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 tendencyto 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.
* information listed above is at the time of submission.