ClariTEE™ probe and Zura™ system receive 510(k) Clearance

ImaCor announces that it has received 510(k) clearance from the U.S. Food and Drug Administration to market the ClariTEE™ probe and the Zura™ imaging system. The ClariTEE™ probe is a miniaturized transesophageal echocardiography probe which facilitates episodic monitoring of cardiac function. The ClariTEE™ 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.

“ImaCor believes that the ClariTEE™ probe will be a major contribution to the care of the critically ill, especially in ICU and perioperative situations” said Scott L. Roth, MD, Chief Executive Officer and a founder of ImaCor. “Current methods of monitoring hemodynamics in this patient population are either invasive, inconclusive, or both. The ClariTEE™ probe is minimally invasive and allows physicians to directly visualize cardiac size and function, and to assess changes as pharmacologic interventions are made,” adds Roth.

 "This is a technology that intensive care physicians have been waiting for,” says Dr. Alexander Levitov, Critical Care section chief at Carilion Roanoke Memorial Hospital in Virginia. Levitov adds, “The ClariTEE™ probe has the potential to become the standard of care in managing hemodynamically unstable patients in the ICU.”

About ImaCor

ImaCor Inc. is a privately held company headquartered in Garden City, NY. The company designs, manufactures, and distributes advanced solutions for hemodynamic assessment in the critical care environment for the purpose of improving patient outcomes and optimizing utilization of healthcare costs. ImaCor manufactures the ClariTEE® probe, the only miniaturized, indwelling TEE probe suitable for long-term clinical settings. hTEE™, Zura™ and ClariTEE® are trademarks of ImaCor, Inc.

Media Contact:

ImaCor, Inc. | Jenn Kujawski |  +1 516 393 0970 |  This email address is being protected from spambots. You need JavaScript enabled to view it.