Healthcare Industry News: cardiac monitor
News Release - March 9, 2010
Scivanta Medical Corporation Announces Results for Initial Clinical Trial for the Scivanta Cardiac Monitoring SystemInitial Clinical Trial Results Meet Company's Expectations
SPRING LAKE, N.J., March 9 (Healthcare Sales & Marketing Network) -- Scivanta Medical Corporation (OTC Bulletin Board:SCVM.ob ), today announced that the results of its initial clinical trial for the Scivanta cardiac monitoring System (SCMS) clearly indicate that the SCMS can accurately measure cardiac performance as expected by the company. This clinical trial was performed at Kaleida Health/Millard Fillmore Hospital in Buffalo, New York.
The initial clinical trial was designed to obtain data concerning the safety and efficacy of the SCMS by comparing mean left atrial pressure measurements obtained from the SCMS to left ventricular end-diastolic pressure readings measured in a simultaneous left heart catheterization procedure performed by a cardiologist in the cardiac catheterization unit. These measurements of cardiac performance are used by physicians in the critical evaluation of a patient's cardiac health.
In the initial clinical trial, the mean left atrial pressure for five patients, as determined by the SCMS, matched the left ventricular end-diastolic pressure, as determined by the left heart catheterization procedure, within 0.1mmHg to 0.5mmHg. This translates into a maximum deviation of 3.3% for the SCMS data when compared to the left heart catheterization data. These results for the SCMS are considered by Scivanta to be highly accurate. There were no adverse events reported during the course of the initial clinical trial.
Richard Berger, M.D., a professor of clinical cardiology at the University of Miami Miller School of Medicine and a fellow of the American College of Cardiology, commented, "Scivanta has conducted an initial clinical trial using a new technique to gather sophisticated, difficult to obtain cardiac hemodynamic information. If the planned subsequent studies confirm the reliability of this technique, physicians will have readily available information that will surely impact positively on the treatment of numerous cardiac and non cardiac patients. This information will be attainable with minimal risk due to the SCMS's relatively non invasive technique. I believe that the SCMS would fit readily into the physician's office, the intensive care unit, the operating room and in all hemodynamic laboratories."
David LaVance, President and Chief Executive Officer of Scivanta, commented, "The results from our initial clinical trial for the SCMS are exciting and show that the SCMS can monitor cardiac performance in a clinically relevant way. We are extremely pleased with the prospects for the SCMS and look forward to commencing our multi-center clinical trials. We anticipate the SCMS having an important role in medicine, especially in the minimally-invasive measurement of cardiac performance."
About Scivanta Medical Corporation
Scivanta Medical Corporation is focused on acquiring and developing medical technologies and products which offer advantages over existing medical procedures and treatments. Scivanta's first product, the Scivanta cardiac monitoring System, formerly known as the Hickey cardiac monitoring System, is an innovative cardiac monitoring system that utilizes a two-balloon esophageal catheter to monitor cardiac performance. The SCMS is expected to provide the primary measurements of cardiac performance in a minimally invasive and cost-effective manner and is designed to be used outside of an intensive care setting. The SCMS is currently under development and must receive the appropriate regulatory approvals prior to commercialization. As Scivanta develops the SCMS, it expects to continue to review for acquisition other medical technologies and products that are sold, or capable of being sold, in a specialty or niche market. For more information, visit www.scivanta.com.
Statements about the Scivanta's future expectations and all other statements in this press release other than historical facts are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and as that term is defined in the Private Securities Litigation Reform Act of 1995. Such statements are subject to certain risks, trends and uncertainties that could cause actual results to differ materially from expected results. Among these risks, trends and uncertainties are economic conditions both generally and within the industries in which Scivanta may participate; competition within Scivanta's chosen industries, including competition from much larger competitors; technological advances; available capital; regulatory approval; and failure by Scivanta to successfully develop or acquire products and form new business relationships. Scivanta intends that such forward-looking statements shall be subject to the safe harbors created thereby. Since these statements involve risks and uncertainties and are subject to change at any time, the Scivanta's actual results could differ materially from expected results.
Source: Scivanta Medical
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