Business Wire05.03.16
Corsens Medical Ltd. has filed a pre-market notification application with the U.S. Food and Drug Administration (FDA) for the Corsens Cardiac Monitor.1,2
The company is seeking the following indications statement for the Corsens Cardiac Monitor: “Corsens records vibrational waveforms produced by the heart contractions and transmitted to the chest wall. Corsens may be used as a tool to measure the timing of part of the events in the cardiac cycle.”
The Corsens Cardiac Monitor is designed to detect cardiac contractility parameters via a series of acoustic, accelerometers and cardiac rhythm non-invasive sensors arrayed on the patient's chest.
"Acute myocardial infarction (MI) remains a leading cause of morbidity and mortality worldwide. Only 15 percent to 20 percent of the patients who suspect that they are having an MI and present to an emergency department have pain of cardiac origin," said Alon Tomas Marmor, M.D.,3 previously clinical professor, Faculty of Medicine at Bar-Ilan University in Israel. "There is an unmet need for a device that can provide a non-invasive and quick assessment of cardiac ischemia. The Corsens Cardiac Monitor has the potential to detect myocardial contractility changes which can direct clinical management of cardiac ischemia."
Marmor has held the positions of clinical/associate professor, Faculty of Medicine at Bar-Ilan University and Technion, Haifa. Marmor has held administrative posts as head of the Heart Institute, head of the Cardiology Division, and chairman of the Cardiology Department at Ziv Government Hospital, Safed. Marmor has served as principle investigator in more than 120 multicenter international clinical trials since 1988.
The Corsens Cardiac Monitor is designed to detect cardiac contractility parameters via a series of acoustic, accelerometers and cardiac rhythm non-invasive sensors arrayed on the patient's chest. The Corsens Cardiac Monitor is intended to provide continuous monitoring of the heart activity with the assessment of patient's condition relative to their cardiac rhythm. Continuous monitoring is critical for detection of myocardial infarction. Rapid detection is critical for patient survival. In previous studies, conducted at the Ziv Medical Center, Safed, Israel,4 the Corsens Cardiac Monitor demonstrated stable, reproducible, and consistent cardiac contractility changes in patients undergoing heart catheterization procedures.5
"We are thrilled to have reached this important milestone in the development of the Corsens Cardiac Monitor with the filing of our pre-marketing notification (510(k)) with the FDA," said Evgeny Fizgeer, CEO of Corsens Medical. "We anticipate significant clinical interest for this innovative technology in the markets where the Corsens Cardiac Monitor will be cleared for commercial distribution. This is the first in a series of regulatory filings, while we continue the development of the Corsens Cardiac Monitor.”
Founded in October, 2013, Corsens Medical is a development stage medical device company based in Tel Aviv, Israel, developing a cardiac monitor.
References
1. Patents pending
2. The Corsense Cardiac Monitor is not approved for sale in the United States or Europe
3. Dr. Marmor is a founder and Chief Medical Officer of Corsense Medical Ltd.
4. Ziv Medical Center was established in 1910 in Safed, affiliated to Bar-Ilan University's Faculty of Medicine. Research cooperation takes place with the Faculty of Medicine and with Migal, the Galilee Research Institute.
5. Company data on file, "Corsens Device For Detection Of Myocardial Ischemia", Clinical Study Report, Protocol No. CS-ANG-1, January 9, 2015
6. Global Cardiac Monitoring Market Growth, Trends & Forecasts (2014 - 2020), July 2015
The company is seeking the following indications statement for the Corsens Cardiac Monitor: “Corsens records vibrational waveforms produced by the heart contractions and transmitted to the chest wall. Corsens may be used as a tool to measure the timing of part of the events in the cardiac cycle.”
The Corsens Cardiac Monitor is designed to detect cardiac contractility parameters via a series of acoustic, accelerometers and cardiac rhythm non-invasive sensors arrayed on the patient's chest.
"Acute myocardial infarction (MI) remains a leading cause of morbidity and mortality worldwide. Only 15 percent to 20 percent of the patients who suspect that they are having an MI and present to an emergency department have pain of cardiac origin," said Alon Tomas Marmor, M.D.,3 previously clinical professor, Faculty of Medicine at Bar-Ilan University in Israel. "There is an unmet need for a device that can provide a non-invasive and quick assessment of cardiac ischemia. The Corsens Cardiac Monitor has the potential to detect myocardial contractility changes which can direct clinical management of cardiac ischemia."
Marmor has held the positions of clinical/associate professor, Faculty of Medicine at Bar-Ilan University and Technion, Haifa. Marmor has held administrative posts as head of the Heart Institute, head of the Cardiology Division, and chairman of the Cardiology Department at Ziv Government Hospital, Safed. Marmor has served as principle investigator in more than 120 multicenter international clinical trials since 1988.
The Corsens Cardiac Monitor is designed to detect cardiac contractility parameters via a series of acoustic, accelerometers and cardiac rhythm non-invasive sensors arrayed on the patient's chest. The Corsens Cardiac Monitor is intended to provide continuous monitoring of the heart activity with the assessment of patient's condition relative to their cardiac rhythm. Continuous monitoring is critical for detection of myocardial infarction. Rapid detection is critical for patient survival. In previous studies, conducted at the Ziv Medical Center, Safed, Israel,4 the Corsens Cardiac Monitor demonstrated stable, reproducible, and consistent cardiac contractility changes in patients undergoing heart catheterization procedures.5
"We are thrilled to have reached this important milestone in the development of the Corsens Cardiac Monitor with the filing of our pre-marketing notification (510(k)) with the FDA," said Evgeny Fizgeer, CEO of Corsens Medical. "We anticipate significant clinical interest for this innovative technology in the markets where the Corsens Cardiac Monitor will be cleared for commercial distribution. This is the first in a series of regulatory filings, while we continue the development of the Corsens Cardiac Monitor.”
Founded in October, 2013, Corsens Medical is a development stage medical device company based in Tel Aviv, Israel, developing a cardiac monitor.
References
1. Patents pending
2. The Corsense Cardiac Monitor is not approved for sale in the United States or Europe
3. Dr. Marmor is a founder and Chief Medical Officer of Corsense Medical Ltd.
4. Ziv Medical Center was established in 1910 in Safed, affiliated to Bar-Ilan University's Faculty of Medicine. Research cooperation takes place with the Faculty of Medicine and with Migal, the Galilee Research Institute.
5. Company data on file, "Corsens Device For Detection Of Myocardial Ischemia", Clinical Study Report, Protocol No. CS-ANG-1, January 9, 2015
6. Global Cardiac Monitoring Market Growth, Trends & Forecasts (2014 - 2020), July 2015