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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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