US FDA clears Tensys' TL-300

SAN DIEGO -- Tensys Medical, Inc., a leader in the development and commercialization of continuous, non-invasive hemodynamic patient monitoring systems has received 510(k) clearance from the US Food and Drug Administration (FDA) for the TL-300, the company’s latest generation system. The TL-300 is a member of Tensys’ established T-Line family, which has successfully been used by over 50,000 patients since commercial launch. The T-Line technology accurately and continuously captures a patient’s beat-to-beat waveform and blood pressure in a completely non-invasive fashion, providing physicians with a stream of real-time hemodynamic data that is not possible using traditional non-invasive blood pressure (cuff) devices. Avoiding the blind time associated with a deflated or inaccurate cuff can enhance hemodynamic monitoring, which has been definitively linked to improved clinical outcomes.

The TL-300 features a tablet supported monitor that allows touch screen control and displays a patient’s key hemodynamic parameters. 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. The tablet 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-300 represents our continued commitment to delivering next generation, non-invasive, hemodynamic monitoring tools,” said Tensys medical director Dr. Oliver Goedje. “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.”

Tensys will be providing additional details regarding the TL-300 launch and other company initiatives at the upcoming 2013 OneMedForum in San Francisco, California. Tensys management will be presenting on January 9^thFootwear