MORRISVILLE, N.C., Oct. 11 /PRNewswire/ — SunTech Medical's Oscar 2(TM) oscillometric 24-hour ambulatory blood pressure monitor (ABPM) has received International Protocol validation, as reported in the August 2004 issue of Blood Pressure Monitoring.
SunTech's Oscar 2 device is the first ABPM device to pass the new blood pressure monitor standard established by the European Society of Hypertension's Working Group on Blood Pressure Monitoring.
The Oscar 2 is a compact, lightweight instrument that provides a cost- effective solution for monitoring patient blood pressure outside the clinical environment. The Oscar 2 is the core of two other SunTech products - The Oscar PowerPack(TM) which includes additional accessories, extended warranty and more powerful ABP report generation software, and the Oscar Express(TM) system, a trans-telephonic device for ABPM particularly effective for clinical research and tele-medicine applications.
The independent evaluation was conducted in the United Kingdom by researchers Stephen C. Jones, MD, a physician with James Cook University Hospital, and James Goodwin, Ph.D. Subjects involved in the study had blood pressure values ranging from moderate hypotension (low blood pressure) to severe hypertension. Results of the study show the Oscar 2 passed for both systolic and diastolic pressures.
"Passing the International Protocol validates the accuracy and repeatability of the Oscar 2," according to Dayn McBee, CEO, SunTech Medical. "We are pleased that the Oscar 2 has now been recommended for clinical use in assessing and monitoring hypertension. This is a powerful tool for diagnosis of hypertension and use in clinical trials."
Hypertension affects approximately 1 billion people worldwide. In the USA, the latest reports indicate that one out of every three people have hypertension. According to researchers, hypertension is expected to increase further as the population ages and as acceptable thresholds for blood pressure change.
In recent years, increasing reliance has been placed on automated ambulatory blood pressure devices to measure blood pressure. The readings from ambulatory devices provide medical professionals with a more complete picture of a patient's blood pressure. These monitors help diagnosis and treatment of various forms of hypertension, including white coat, resistant hypertension, nocturnal hypertension etc.
"One of the great advantages of ambulatory blood pressure monitoring is that the physician does not need to be with their patient in order to collect valuable diagnostic information," said McBee. "Because the monitoring is unattended, successful ambulatory monitoring depends upon the quality and performance of the device. At SunTech, everything we do revolves around producing automated BP technology that provides the highest level of clinical accuracy and reliability possible."
SunTech Medical, Inc., located in Morrisville, N.C., is the world leader in motion-tolerant non-invasive blood pressure monitoring products and technology. SunTech has products for 24-hour ambulatory BP monitoring, exercise stress BP monitoring and a customizable OEM BP module. SunTech has ISO9001-2001 and ISO13485 accreditation. The Oscar 2 has obtained FDA 510(K) clearance and is CE marked. For more information refer to SunTech's Web site, http://www.suntechmed.com/