US-based Tensys Medical has received CE Mark approval for both the TL-400 & TL-300 next-generation continuous, non-invasive hemodynamic patient monitoring systems.
Approval allows Tensys to immediately commercialise the systems in Europe.
The TL-400 captures patient’s real-time advanced hemodynamic data in a completely non-invasive fashion and with a simple press of the button, it quickly displays data. It is a new addition to Tensys’s established T-Line family and offers a Hemopath view, which displays a one-view-see-all on a single screen, providing the physician with a comprehensive hemodynamic snapshot of the patient.
The TL-300, which has clearance in the US and Chinese markets, uses Tensys’s T-Line technology to accurately and continuously capture a patient’s beat-to-beat waveform and blood pressure in a non-invasive fashion that is not possible with other available conventional devices.
Tensys COO Dr Jamie Sulley said the TL-400 and TL-300 represented significant advances in non-invasive, hemodynamic monitoring tools.
"Measuring advanced hemodynamic parameters in a completely non-invasive fashion opens new avenues in critical care as these platforms display vital patient data with almost zero patient risk," Dr Sulley said.
The touchscreen user interface of the devices helps the operator in easy analysis of the trend data for up to a 12-hour period.
The screen displays data coming from an integrated bracelet, sensor, and wrist frame placed over the patient’s radial artery.
The bracelet and sensor can be used immediately for the next patient after the wrist frame gets disposed at the end of the each case.
T-line products are used in a number of clinical environments including the operating room, intensive care unit (ICU), and electrophysiology lab.