SAN DIEGO /BUSINESS WIRE/ -- Tensys Medical Inc., a leader in the development and commercialization of continuous, noninvasive hemodynamic patient monitoring systems, has received CE Mark for both the TL-400 and TL-300, the company's latest generation systems. This will allow immediate commercialization of the systems throughout Europe.
The TL-400 is a new member of Tensys' established T-Line family, which has successfully been used by over 50,000 patients since its commercial launch. In addition to capturing a patient's beat-to-beat waveform and blood pressure in a completely noninvasive fashion, a simple touch of a button prompts the TL-400 to continuously display a patient's advanced hemodynamic parameters, including, but not limited to, cardiac output, cardiac power, systemic vascular resistance, stroke volume variation, and pulse pressure variation.
The TL-400 provides physicians with a stream of real-time advanced hemodynamic data that was only previously available using either highly invasive (pulmonary artery catheter and femoral artery thermodilution) devices or less invasive (radial artery pulse contour analysis) technologies. The sister TL-300, already cleared in the U.S. and China markets, displays a patient's beat-to-beat arterial waveform and blood pressure, avoiding the blind-time associated with a deflated or inaccurate cuff. Both the TL-400 and TL-300 can enhance overall hemodynamic monitoring, which has been definitively linked to improved clinical outcomes.
Both devices have a sleek, touch-screen user interface, and the operator is readily able to view trend data for up to a 12-hr. period. In addition, the TL-400 offers the innovative Hemopath view, which displays a one-view-see-all on a single screen, providing the physician with an easy to understand, yet comprehensive hemodynamic snapshot of the patient. The screen displays 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. Today, the T-line family is used in a number of clinical environments, including the operating room, intensive care unit (ICU), and electrophysiology lab.
"The TL-400 and TL-300 represent significant advances in noninvasive, hemodynamic monitoring tools," commented Dr. Jamie Sulley, Tensys' Chief Operating Officer. "Measuring advanced hemodynamic parameters in a completely noninvasive fashion opens new avenues in critical care as these platforms display vital patient data with almost zero patient risk," added Dr. Sulley.
Tensys Medical Inc. is a leader in the development and commercialization of continuous, noninvasive, hemodynamic monitoring systems. Without a single needle stick, the company's FDA-approved and CE-marked T-line technology is used today in hospital operating rooms, ICUs, and electrophysiology labs to provide a patient's real-time pulse pressure waveform and blood pressure. With the future addition of advanced hemodynamic parameters, Tensys is positioned to continue its leadership in the growing, noninvasive, hemodynamic marketplace.