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  Chris Jones
Chief Executive Officer
Tensys Medical, Inc.
Phone 858.552.1941
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Tensys® Medical Launches First Real-Time, Non-Invasive Blood Pressure Monitoring Device

Commercial Distribution Begins After Clinical Evaluation in Over 500 Surgical Cases

 

SAN DIEGO, CA - April 21, 2003 - Tensys Medical, the 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, Chief Executive Officer, 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," continued Martin.

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, M.D., Division Chief, Anesthesia at Waukesha Memorial Hospital, located about 20 miles west of Milwaukee, 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 Dr. Wakefield.

"At Tensys Medical, we believe anesthesia to be a medical miracle," continued Tensys Medical's Martin. "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%.

About Tensys® Medical

Tensys Medical, Inc. is the leader in real-time blood pressure management. The Tensys T-Line®, the company's lead product, 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.

Tensys Medical is based in San Diego, California and was founded in November 1995. For more information, please visit the company's Web site at www.tensysmedical.com.

Company Contacts:

Bill Markle
Vice President, Marketing & Business Development
Tensys Medical, Inc.
858.522.1941 x211
bmarkle@tensysmedical.com

Media Contacts:

James Forte or Maureen O'Donnell
Townsend Inc.
858.457.4888
jforte@townsendinc.com
modonnell@townsendinc.com

 
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