May 1, 2008 – Portland, Oregon Tiba Medical, a provider of non-invasive medical diagnostic systems, today announced that its Ambulo™ 2400 ambulatory blood pressure monitoring (ABPM) system have received 510(k) market clearance from the United States Food & Drug Administration (FDA).The Ambulo 2400 ABPM system providers primary care, cardiology and nephrology clinics as well as hypertension researchers the state-of-the-art in 24-hour blood pressure monitoring. The Ambulo 2400 includes a built-in actigrapher that tracks activity levels during the study period and automatically categorizes activity/rest cycles hence improving the analysis of the patient’s blood pressure over the full circadian rhythm.
“Numerous clinical studies have demonstrated that ABPM is a superior predictor of cardiovascular risk, circulatory failure and target organ damage” said Dr. Arash Tirandaz, MD, FACP, Tiba Medical’s Chief Medical Officer. “While ABPM technology has been around for some time, the inclusion of actigraphy along with our patented oscillometric algorithm in a sleek, complete and affordable package enables physicians to better diagnose and manage hypertensive patients” said Dr. Tirandaz.
The Ambulo 2400 system has been validated according to the AAMI SP-10 and the British Hypertension Society’s protocols achieving an A/A grade. The system includes many innovations that improve patient comfort and compliance while ensuring accurate and reliable measurements over the life of the system. This includes the optional EasyWear™ cuff for wearing the device directly on the cuff, the intuitive and powerful Hypertension Diagnostics Suite software as well as solid-state technology that can store up to 3000 blood pressure measurements and 7 days of actigraphy.
The Ambulo 2400 is available for purchase, lease or short-term rental directly from Tiba Medical as well as a number of distribution partners across the United States. The system will be available in the European Union and beyond in Q4 2008. Tiba Medical is actively seeking scientists and clinical researchers to utilize the Ambulo 2400 as part of their upcoming clinical studies in hypertension and cardiac safety.
About Tiba Medical
Based in Portland, Oregon, Tiba Medical offers innovative and affordable solutions for noninvasive diagnosis, and monitoring of patients. Tiba Medical’s is an FDA-registered establishment and certified to be compliant with the ISO 13485:2003, acknowledging that Tiba Medical meets quality system requirements that are recognized across the world. For more information about Tiba Medical and its products please visit our web site at www.tibamedical.com
PHOTOS: High resolution and low resolution pictures of the Ambulo 2400 are available online on the Tiba Medical Image Bank.