CNSystems Medizintechnik AG Receives FDA Approval For CNAP™ Blood Pressure Monitor 500

Main Category: Medical Devices / Diagnostics
Also Included In: Hypertension;  Regulatory Affairs / Drug Approvals
Article Date: 10 Nov 2008 - 8:00 PST

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CNSystems Medizintechnik AG, a medical device company marketing CNAP™, today announced that the U.S. Food and Drug Administration has cleared the 510(k) notification for CNSystem's CNAP™ Monitor 500, permitting the sale of this product in the United States.

The CNAP™ 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™ 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™ 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 € 150 million per year (approx. $190 million p.a.)."

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About CNAP™ and CNSystems Medizintechnik AG

CNSystems markets CNAP™, the first continuous, non-invasive blood pressure management system ready for day-to-day clinical use. CNAP™ 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™ directly to clinicians as CNAP™ Monitor 500, which is compatible with the leading patient monitoring systems on the market. CNAP™ 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.

CNSystems Medizintechnik AG