Haemonetics won FDA clearance for its TEG 6s Hemostasis Analyzer System to be used in adult trauma settings to evaluate the viscoelasticity of patients’ blood.
The system relies on an all-in-one cartridge into which a small sample of blood is placed. The cartridge already has the necessary reagents within itself, automatically mixing them with the blood and then running up to four assays at the same time inside the machine. Because the reagent mixing process does not involve any human interaction aside from placing a sample inside, there’s a much reduced chance for errors. Moreover, the entire testing process is faster than performing traditional blood tests, the results coming in within about ten minutes.
The TEG 6s already has FDA clearance for use in cardiovascular surgery and cardiology procedures, so the new indication will greatly expand its applications.
Here’s some detail about the study that led to the new clearance:
The 510(k) clearance was based on clinical data from a multicenter, multistate trial of approximately 500 adult patients comparing the TEG® 5000 Hemostasis Analyzer System, which has been used in trauma for over a decade, to the next-generation TEG 6s system. The study collected more than 150,000 data points and showed that the TEG 6s system is reliable, substantially and analytically equivalent and test results can be interpreted like those from the TEG 5000 system when used in a trauma setting.
Product page: TEG 6s