ImaCor Receives FDA Clearance for ClariTEE Probe, Zura Imaging System
July 30, 2008 - ImaCor today said it received FDA 510(k) clearance to market the ClariTEE miniaturized transesophageal echocardiography probe and the Zura ultrasound imaging system.
The ClariTEE probe facilitates episodic monitoring of cardiac function. It is a single use device that can remain indwelling for up to 72 hours, allowing intensivists and anesthesiologists to periodically assess cardiac preload and left ventricular systolic function over a prolonged period of time.
The company said current methods of monitoring hemodynamics in ICU and perioperative patients are either invasive, inconclusive, or both. The ClariTEE probe is minimally invasive and reportedly allows physicians to directly visualize cardiac size and function, and to assess changes as pharmacologic interventions are made.
“This is a technology that intensive care physicians have been waiting for,” said Dr. Alexander Levitov, critical care section chief at Carilion Roanoke Memorial Hospital in Virginia. “The ClariTEE probe has the potential to become the standard of care in managing hemodynamically unstable patients in the ICU.”
For more information: www.imacormonitoring.com.