FDA Clears Cheetah Medical NIBP Parameter for its NICOM Hemodynamic Monitoring System
January 9, 2009 - Cheetah Medical said this week it was granted FDA 510(k) marketing clearance for the noninvasive blood pressure (NIBP) functionality, provided by SunTech Medical, in its NICOM Reliant Hemodynamic Monitoring System.
The approval provides a comprehensive suite of information for functional cardiac and systemic vascular monitoring without the need for invasive cardiovascular monitoring methods that are associated with increased potential costs and patient risks. The new parameters include noninvasive blood pressure (NIBP), total peripheral resistance (TPR), stroke volume variation (SVV), cardiac power (CP), and change in thoracic fluid content (TFCd). The NIBP Option for NICOM hemodynamic monitoring systems sold in the U.S. is the product of an ongoing global OEM agreement between Cheetah Medical and SunTech Medical.
Cheetah patented BIOREACTANCE Technology noninvasively measures stroke volume (SV) and cardiac output (CO) with validated accuracy compared to invasive methodologies, the company said. BIOREACTANCE technology has been used to monitor more than 2,000 patients effectively in a variety of clinical settings including medical and surgical intensive care, perioperative care, emergency medicine, heart failure, hemodialysis and exercise testing. Numerous clinical studies validating the performance and clinical efficacy of BIOREACTANCE Technology have been published to-date in peer-reviewed medical publications worldwide, with more studies underway.
Live demonstrations of the NICOM System with NIBP capabilities will be available at the 38th Critical Care Congress of the Society of Critical Care Medicine in Nashville, TN, Jan. 31 – Feb. 3, 2009.
For more information: www.cheetah-medical.com