- 10.11.2008, 14:38:12
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- OTE0012
CNSystems Medizintechnik AG receives FDA Approval for CNAP(TM) Monitor 500
Graz (OTS) - CNSystems Medizintechnik AG, a medical device company
marketing CNAP(TM), today announced that the U.S. Food and Drug
Administration has cleared the 510(k) notification for CNSystem's
CNAP(TM) Monitor 500, permitting the sale of this product in the
United States.
The CNAP(TM) Monitor 500 measures non-invasive and continuous
blood pressure in real-time and can predict responsiveness to fluid
administration. In the perioperative setting, detecting blood
pressure drops and their cause in time is crucial for peri- and
postoperative outcome. However, until recently only invasive methods
provided quality information to the clinician. CNAP(TM) provides
reliable blood pressure monitoring comparable to invasive techniques
and adds valuable information about fluid responsiveness of the
patient non-invasively. This allows spreading the highest level of
blood pressure monitoring to all perioperative settings where close
blood pressure monitoring is indicated, but the risk and discomfort
of invasive measurement is not justified.
"CNAP(TM) is very well received amongst Europe’s anesthesiologists
in only a short time," commented Dr. Juergen Fortin, CEO of
CNSystems, "and we are confident that the same will be true in the
USA where the perioperative market for continuous non-invasive blood
pressure control is even more promising, with an estimated sales
potential of Euro 150 million per year (approx. $190 million p.a.)."
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About CNAP(TM) and CNSystems Medizintechnik AG
CNSystems markets CNAP(TM), the first continuous, non-invasive
blood pressure management system ready for day-to-day clinical use.
CNAP(TM) offers clinicians an easy-to-use and efficient way to
measure the blood pressure and control the fluid state without
discomfort to the patient. The system is appropriate to the majority
of patients in perioperative settings where close blood pressure
monitoring is indicated but the risk and discomfort of invasive
measurement is not justified. CNSystems offers CNAP(TM) directly to
clinicians as CNAP(TM) Monitor 500, which is compatible with the
leading patient monitoring systems on the market. CNAP(TM) is also
available as module and can be integrated within other monitoring
systems by medical device manufacturers. CNSystems is a private
company located in Graz, Austria. Further information on CNSystems
can be found at www.cnsystems.at .
Picture and logo can be downloaded at:
http://www.cnsystems.at/fileadmin/user_upload/_temp_/PA_Material.zip
Rückfragehinweis:
Christopher Arbeiter
Head of Sales & Marketing
CNSystems Medizintechnik AG
Tel.: +43 (0) 316 7234560
mailto:office@cnsystems.at
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