Scivanta Medical has presented the results of initial clinical trial of Cardiac Monitoring System (SCMS). The 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 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 accurate. There were no adverse events reported during the course of the initial clinical trial.
Richard Berger, a professor of clinical cardiology at the University of Miami Miller School of Medicine and a fellow of the American College of Cardiology, said: “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, said: “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 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.”