Syntermed Receives FDA Clearance for AdreView Tools™
Atlanta, GA (PRWEB) October 01, 2013 -- Syntermed, Inc. receives 510(k) clearance from the Food and Drug Administration for AdreView Tools™. This diagnostic imaging software is used in conjunction with GEHealthcare’s recently FDA approved imaging agent AdreView (Iobenguane 1123 injection) -- the first FDA approved molecular imaging agent in the U.S. to link nerve function in the heart to a patient’s heart failure mortality risk.
AdreView Tools was 510(k) cleared on June 18, 2013 by the FDA for an expanded indication: first, for the quantitative analysis and display of SPECT AdreViewTM (123I-mIBG) data sets used for evaluation of patients with congestive heart failure, and second, AdreView Tool can be used for the quantitative analysis of SPECT studies. "The other important difference, said Ken Van Train, President, Syntermed, Inc., "is in the cutoff used for determining if the patient has an abnormal heart-to- mediastinum (H/M) ratio." The validation document in the FDA submission included a patient population of 926 heart failure patients used for both the planar and SPECT validation using 90 controls.
Ernest V. Garcia, PhD, Director of Nuclear Cardiology R&D at Emory University lead the development of AdreView Tools software. This software is now licensed to Syntermed, Inc. as the newest addition to the Emory Toolbox for SPECT imaging. "Predicting heart failure and the risk of sudden death in men and women who already have had one heart failure episode can be difficult and the diagnostic tools are limited. Now with AdreView, the injectable imaging agent and AdreView Tools, the SPECT imaging software, a complete package helps physicians get a numeric score to predict mortality risk and provide earlier information about the molecular structure of the heart," said Dr. Garcia.
The imaging agent AdreView is injected as part of the SPECT heart study and evaluates the neuronal capacity for the update and storage of norepinephrine (NE) in the heart, recording the H/M ratio as an evaluation of the functionality of the sympathetic nerves in the heart. In clinical studies, an AdreView score of 1.6 was associated with a 99 percent likelihood of survival at one year (negative predictive value). Patients who have endured one heart failure event are six to nine times more likely to experience sudden death from heart failure.
"At Syntermed, we are continually identifying how to improve workflow in the nuclear cardiology lab and add tools to the Emory Toolbox that better define the heart condition," said Ken Van Train, President, Syntermed, Inc. "AdreView Tools is our newest addition to the Emory Toolbox and will be automatically part of the Emory Toolbox version 4.0 update that is currently underway throughout nuclear cardiology labs in the U.S. AdreView Tools can be installed on any SPECT imaging hardware system that uses the AdreView agent."
Facts about Heart Failure according to Emory University’s Vascular Center: Heart Failure contributes to 287,000 deaths per year in the United States. African Americans are more likely to develop heart failure than other races. Each year, heart failure generates at least 11 million physician visits and more hospitalizations than all forms of cancer combined. Congestive heart failure is the first-listed diagnosis in 875,000 hospitalizations, and the most common diagnosis in hospital patients age 65 years and older.
[Disclosure: Dr. Garcia and Emory University receive royalties from Syntermed for the licensed technologies. Additionally, they own equity in Syntermed. The terms of the arrangement have been reviewed and approved by Emory University in accordance with its conflict of interest policies.]
About Syntermed:
Syntermed, Inc. is an Atlanta-based imaging and informatics software company that serves nuclear cardiology and nuclear medicine labs with its quantification and decision support software. Since 1999 Syntermed software has been utilized on SPECT and PET imaging systems. Today, the Emory Toolbox, now in its fourth generation, is one of the most widely applied methods of cardiac imaging, used in nearly half of all nuclear medicine labs nationwide. For advanced phase analysis imaging studies of left ventricle dyssynchrony, Syntermed offers SyncTool™. For brain scan images using PET, Syntermed’s NeuroQ™ is the most widely used commercially quantitative solution in the world. All of Syntermed’s software is compatible with virtually any nuclear medicine workstation or PC/MAC that supports Microsoft® Windows® operating system. Syntermed Live enables physicians to access images and reports using computer access from a secure server at any time of the day.
Karen Roberts, Syntermed,Inc., http://www.syntermed.com, +1 3177305349, [email protected]
Share this article