Tensys Medical Launches First Real-Time, Non-Invasive Blood Pressure Monitoring Device

SAN DIEGO -- Tensys Medical, a leader in real-time blood pressure management, today announced the launch of the Tensys T-Line, an FDA-cleared medical device providing anesthesiologists better, more effective control over patient safety during surgery by allowing them to quickly monitor and manage blood pressure variations.

There are currently two primary methods used by anesthesiologists to monitor blood pressure during surgery. The T-Line, via its continuous, real-time data, is far more effective than the traditional cuff method and has clinically equivalent accuracy to that of the arterial line (A-line). The Tensys device uses a transdermal pressure sensor to continuously, yet non-invasively measure blood pressure at the radial artery.

"Tensys has worked to bring the anesthesiologist's job to an even higher level of excellence by providing a real-time, non-invasive blood pressure management tool in the T-Line," stated Michael J. Martin, CEO of Tensys Medical. "In contrast, the cuff, which is the anesthesiologist's current tool, provides only intermittent readings once every three-to-five minutes at best. Significant changes to the cuff have not been made since the 1970's and yet it is currently used in 9 out of 10 surgeries. The Tensys T-Line is a much-needed advancement," Martin added.

Prior to its official product launch, the Tensys T-Line was tested in approximately 500 surgical cases nationwide over the past six years during which several key benefits were identified. The Tensys T-Line:

* Provides a more accurate means of monitoring blood pressure trends such

as low or high swings in real-time.

* Allows the anesthesiologist to move from reactive to proactive,

facilitating real-time blood pressure management rather than

intermittent readings every 3-5 minutes at best when using the cuff.

* Is non-invasive and thus eliminates patient-related and

anesthesiology-related risks associated with the invasive A-line such

as infection or blood-borne diseases.

* Has the clinically equivalent accuracy of an A-line, yet is

non-invasive.

* Is easily applied and provides direct measurement without external

calibration.

* Rapidly adjusts to patient movement.

* Displays a high-fidelity waveform on standard operating room monitors

or on its own screen demonstrating real-time measurement and

monitoring.

Top anesthesiologists have also noted that the Tensys T-Line can significantly extend the anesthesia safety net to address the issues of hemodynamic instability in much the same manner that oximetry has reduced the occurrence of respiratory mishaps during anesthesia.

"I personally experienced the effectiveness and accuracy of the T-Line first-hand in the operating room," stated David W. Wakefield, MD, division chief of anesthesia at Waukesha Memorial Hospital in Wisconsin. "The T-Line literally predicted the next reading of the cuff. The T-Line hit 150/98 while the cuff was reading a three-minute old and much lower number at 90/75. I waited to see the cuff's next reading. Thirty seconds later, the cuff cycled and hit almost exactly the same reading. I was convinced that the T-Line really worked. For the first time I can non-invasively manage blood pressure in real-time," continued Wakefield.

"At Tensys Medical, we believe anesthesia to be a medical miracle," Martin said. "Anesthesiologists are able to temporarily paralyze a patient for surgery and alter their ability to feel pain. These concepts along with the ability to reverse those effects without any damage are truly remarkable. We feel that anesthesiologists are undervalued and taken for granted in our society considering they are in a profession where job accuracy must approximate 100 percent.

The Tensys T-Line was cleared by the FDA in November 2002 as a medical device providing anesthesiologists with a non-invasive, continuous real-time blood pressure management tool.

The Tensys T-Line measures a patient's blood pressure at the radial artery. It offers anesthesiologists better, more effective control over patient safety during surgery by allowing them to quickly monitor and manage blood pressure variations. The T-Line, via its continuous, real-time data, is far more effective than the traditional cuff method and has clinically equivalent accuracy to that of the arterial line (A-line). The device is based on Tensymetry, the company's proprietary and patented technology, for non-invasively extracting the continuous, beat-to-beat pressure waveform from the radial artery without the use of any external calibration device. The science of Tensymetry is broadly protected and is the result of over six years of research and development. Prior to its official product launch in March 2003, the Tensys T-Line was tested in approximately 500 surgical cases nationwide.

Source: Tensys Medical, Inc.

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