Medwave, Inc. Submits Vasotrac(R) APM205A for FDA 510(k) Review, for Use On Pediatric Patients

Apr 17, 2001, 01:00 ET from Medwave, Inc.

    ST. PAUL, Minn., April 17 /PRNewswire/ -- Medwave, Inc. (Nasdaq:   MDWV)
 announced today that it has submitted its 510(k) for Pediatric use of its
 Vasotrac APM205A Continual Non-Invasive Blood Pressure Monitor to the US Food
 and Drug Administration for review.
     Medwave's Vasotrac is designed for measuring a patient's blood pressure on
 a continual basis, with updates available approximately every 15 heartbeats.
 The Vasotrac is being marketed in several major countries in the world,
 including the United States for adult patients.  The Vasotrac is currently
 being used in anesthesiology, critical care, emergency rooms, and cardiology
 departments.  In some cases when a patient requires an arterial catheter only
 for monitoring blood pressure on a continual basis, Vasotrac users have
 reported a reduced need for A-lines.  A study presented in October 2000, as a
 part of the American Society of Anesthesiologists, highlighted the use of the
 Vasotrac with Patients under 4 years of age with very good correlation.  For
 the past several months, Arkansas Childrens Hospital has conducted additional
 studies which compared the Vasotrac to an arterial catheter.  The results
 were, that the correlation of the Vasotrac to the A-line show a mean
 correlation of greater than 0.92.  This study was done on patients in the age
 range of 1 year to 17 years old.
     Medwave, Inc. headquartered in St. Paul, Minn., USA, develops and
 manufactures non-invasive blood pressure products.  Its Vasotrax hand-held
 monitor and the Vasotrac(R) APM205A monitor, the company's related monitoring
 system, are new approaches to non-invasive blood pressure monitoring.  The
 company trades on the NASDAQ small cap market under the symbol MDWV.
     Statements made in this release that are stated as expectations, plans,
 beliefs, anticipations, prospects or future estimates or which otherwise look
 forward in time are considered "forward-looking statements" and involve a
 variety of risks and uncertainties, known and unknown, which are likely to
 affect the actual results.  The following factors, among others, as well as
 factors discussed in the company's filings with the SEC, have affected and, in
 the future, could affect the company's actual results:  resistance to the
 acceptance of new products, the market acceptance of the Vasotrac(R) monitor,
 the Vasotrax(TM) hand-held monitor, and other products of the company,
 hospital budgeting cycles, the possibility of adverse or negative commentary
 from clinical researchers or other users or evaluators of the company's
 products, the company's success in creating effective distribution channels
 for its products, the company's ability to scale up its manufacturing process,
 and delays in product development or enhancement or regulatory approval.
 Consequently, no forward-looking statement can be guaranteed and actual
 results may vary materially.
 
 

SOURCE Medwave, Inc.
    ST. PAUL, Minn., April 17 /PRNewswire/ -- Medwave, Inc. (Nasdaq:   MDWV)
 announced today that it has submitted its 510(k) for Pediatric use of its
 Vasotrac APM205A Continual Non-Invasive Blood Pressure Monitor to the US Food
 and Drug Administration for review.
     Medwave's Vasotrac is designed for measuring a patient's blood pressure on
 a continual basis, with updates available approximately every 15 heartbeats.
 The Vasotrac is being marketed in several major countries in the world,
 including the United States for adult patients.  The Vasotrac is currently
 being used in anesthesiology, critical care, emergency rooms, and cardiology
 departments.  In some cases when a patient requires an arterial catheter only
 for monitoring blood pressure on a continual basis, Vasotrac users have
 reported a reduced need for A-lines.  A study presented in October 2000, as a
 part of the American Society of Anesthesiologists, highlighted the use of the
 Vasotrac with Patients under 4 years of age with very good correlation.  For
 the past several months, Arkansas Childrens Hospital has conducted additional
 studies which compared the Vasotrac to an arterial catheter.  The results
 were, that the correlation of the Vasotrac to the A-line show a mean
 correlation of greater than 0.92.  This study was done on patients in the age
 range of 1 year to 17 years old.
     Medwave, Inc. headquartered in St. Paul, Minn., USA, develops and
 manufactures non-invasive blood pressure products.  Its Vasotrax hand-held
 monitor and the Vasotrac(R) APM205A monitor, the company's related monitoring
 system, are new approaches to non-invasive blood pressure monitoring.  The
 company trades on the NASDAQ small cap market under the symbol MDWV.
     Statements made in this release that are stated as expectations, plans,
 beliefs, anticipations, prospects or future estimates or which otherwise look
 forward in time are considered "forward-looking statements" and involve a
 variety of risks and uncertainties, known and unknown, which are likely to
 affect the actual results.  The following factors, among others, as well as
 factors discussed in the company's filings with the SEC, have affected and, in
 the future, could affect the company's actual results:  resistance to the
 acceptance of new products, the market acceptance of the Vasotrac(R) monitor,
 the Vasotrax(TM) hand-held monitor, and other products of the company,
 hospital budgeting cycles, the possibility of adverse or negative commentary
 from clinical researchers or other users or evaluators of the company's
 products, the company's success in creating effective distribution channels
 for its products, the company's ability to scale up its manufacturing process,
 and delays in product development or enhancement or regulatory approval.
 Consequently, no forward-looking statement can be guaranteed and actual
 results may vary materially.
 
 SOURCE  Medwave, Inc.