Haemonetics (NYSE:HAE) said on Monday that it won expanded FDA 510(k) clearance for its TEG 6s hemostasis analyzer system, now indicated for use in adult trauma settings.
The TEG 6s system is comprised of an analyzer, disposable cartridges and software and is intended to provide a rapid and accurate identification of a patient’s hemostasis condition, the Braintree, Mass.-based company said.
Haemonetics touted the TEG 6s as the first cartridge-based system available in the U.S. to evaluate hemostasis conditions in adult trauma patients. The system previously won indications for use in cardiovascular surgery and cardiology systems, the company said.
“The TEG 6s system brings a new level of simplicity, consistency and speed to the coagulation testing process when every moment counts. Acute care clinicians can quickly and confidently get a complete picture of a trauma patient’s hemostasis condition right in the ER or trauma bay,” hemostasis management and cell salvage global marketing and strategy VP Eva Casamento said in a prepared statement.
Approval of the device came based on data from a trial of approximately 500 adult patients comparing the TEG 5000 hemostasis analyzer system with the next-gen TEG 6s system, the company said. Results showed the TEG 6s system as reliable, substantially and analytically equivalent.
“The TEG 6s analyzer is an important tool for trauma centers needing fast access to information about critically injured patients. What makes TEG 6s unique in trauma settings is the easy to operate cartridge-based system with rapid results at the site of care. The broad set of trauma-relevant parameters including LY 30, which measures clot lysis, allows clinicians to more accurately determine the best, tailored treatment option for each individual patient.” medical affairs VP Dr. Jan Hartmann said in a press release.
Earlier this month Haemonetics said that it agreed to sell a plant in South Carolina to CSL Plasma for $10 million.
