Tensys Medical's new continuous, non-invasive hemodynamic patient monitoring system has obtained 510(k) clearance from the US Food and Drug Administration (FDA).
The TL-300 system, a member of T-Line family, is designed for use in operating room, intensive care unit (ICU), and electrophysiology lab.
Using T-Line technology, the system accurately and continuously captures a patient's beat-to-beat waveform and blood pressure in a non-invasive fashion, which is not possible using traditional non-invasive blood pressure (cuff) devices.
Avoiding the blind-time associated with a deflated or inaccurate non-invasive blood pressure cuff can enhance hemodynamic monitoring, which has been definitively linked to improved clinical outcomes, claims the company.
In addition to continuous beat-to-beat blood pressure and arterial waveform, the operator is readily able to view trend data for up to a 12-hour period.
Featuring a tablet supported monitor that allows touch screen control, the system displays real-time hemodynamic data coming from an integrated bracelet, sensor, and wrist frame placed over the patient's radial artery.
The wrist frame is disposed at the end of the case and the bracelet and sensor are immediately available for the next patient.
Tensys medical director Dr Oliver Goedje said, "This new system will not only enhance our current product offering, but will serve as a platform as we add cardiac output and additional hemodynamic parameters in the near future."
