FDA Approves First Clinical Application of PAT(TM) Technology For Use In Cardiovascular Diseases

Itamar Medical Introduces Breakthrough Technology for Assessing Autonomic

Nervous System Activity



Noninvasive, Finger-Mounted Probes Detect Subtle Physiological Changes;

Potential Applications In Cardiovascular and Sleep Disorders



Apr 04, 2001, 01:00 ET from Itamar Medical

    CAESAREA, Israel, April 4 /PRNewswire/ -- Itamar Medical announced today
 that the FDA has approved the first clinical application of its pioneering
 technology to measure PAT (Peripheral Arterial Tone), a powerful signal which
 monitors peripheral vascular responses to autonomic nervous system activity.
 Clinical studies at leading institutions worldwide are demonstrating that
 analysis of the PAT Signal can provide clinicians with highly sensitive and
 accurate indicators to help identify, diagnose and monitor a variety of
 medical conditions. The FDA Class II approval announced today is for Itamar's
 ETT_PAT 2000 product, the first member of Itamar's Cardio_PAT line of devices,
 for use in ECG stress testing for the detection of myocardial ischemia.
     "Almost 20 million people have cardiac risk factors that may make them
 candidates for medical or surgical intervention and only 20-25% of them are
 being treated.  Many of these patients are at risk for future heart attack and
 often the ECG Stress Test is not sensitive enough to identify those at most
 risk," noted Alan Rozanski, MD, Professor of Medicine at Columbia University
 College of Physicians and Surgeons and a PAT investigator.  "In the FDA trial,
 use of PAT significantly increases the sensitivity of the Exercise Stress Test
 without loss of specificity.  The PAT represents a significant increase in our
 ability to diagnose disease accurately and possibly earlier, offering the
 opportunity to identify new populations of individuals who are candidates for
 more cost-effective early interventions."
     In studies with over 2,000 patients, the PAT increased the sensitivity of
 the exercise stress test by 30% without loss of specificity and reduced
 non-definitive tests by over 50%.
     The PAT signal accurately measures arterial pulsatile volume changes in
 the fingertip, which have been shown by Itamar to mirror changes or anomalies
 in autonomic nervous system activity and their related vascular events.  In
 the application of PAT technology whose approval is being announced today,
 easy-to-use, noninvasive finger mounted probes are used in conjunction with
 the ECG during standard exercise stress testing.
     "The PAT signal is an entirely new window into human physiology," said
 Barry L. Zaret, M.D., Professor of Medicine, Chief Section of Cardiovascular
 Medicine, Yale University School of Medicine and Medical Director, Yale New
 Haven- Heart Center. "Cardiovascular response to autonomic nervous system
 regulation can be independent of the patient's blood pressure, oxygen
 saturation or ECG changes. This approval opens the door to new ways of
 understanding and managing cardiovascular, respiratory and nervous system
 disorders with low-cost clinical applications that are more sensitive than our
 current tools."
     Itamar Medical has developed proprietary technologies, including
 non-invasive finger probes and advanced digital signal processing algorithms,
 to evaluate the PAT Signal in a number of important clinical applications
 including hypertension, myocardial ischemia, congestive heart failure,
 cardiovascular and peripheral vascular disorders, neurologic disorders, sleep
 medicine, and the early diagnosis of the vascular consequences of metabolic
 diseases like diabetes.  PAT-based technologies for screening, diagnostic,
 treatment assessment and follow-up are now undergoing evaluations in leading
 clinical centers at institutions worldwide including Columbia University,
 Harvard, Johns Hopkins, Mayo Foundation, Sahlgrenska University Hospital,
 Stanford, Tufts, and Yale.
     "This first regulatory approval both paves the way for the initial
 marketing and licensing of our PAT-based technology, and also serves as a
 testament to the strength of the basic research," states Israel Schreiber,
 President and Chief Executive Officer of Itamar Medical. "Itamar Medical is
 now uniquely poised to meet the diagnostic and follow up needs of the medical
 community by offering a family of safe, easy to use, non-invasive and highly
 sensitive additions to the physician's arsenal."
 
     About Itamar Medical
     Itamar Medical Ltd. is pioneering basic research into the autonomic
 nervous system integration of the cardiorespiratory and vascular systems.
 This basic research has resulted in the identification and development of the
 PAT (peripheral arterial tone) Signal -- a new physiologic signal with
 important implications for cardiology, and sleep medicine, as well as basic
 research in autonomic regulation of peripheral vasculature.  Itamar holds
 patents on the use of the PAT Signal for medical purposes and a growing body
 of proprietary technologies -- hardware, software, and signal processing
 algorithms -- to allow applications of the PAT signal in many areas of
 clinical medicine.  Itamar Medical, established in 1997, is headquartered in
 Caesarea, Israel and has received investment and technical support from global
 medical technology leader Medtronic Inc. To learn more about the PAT signal
 and Itamar Medical, visit http://www.itamar-medical.com.  For further
 information; email contact@itamar-medical.com, or phone 1-800-206-6952 (from
 the US only) or +972-4-617-7000.
 
 

SOURCE Itamar Medical
    CAESAREA, Israel, April 4 /PRNewswire/ -- Itamar Medical announced today
 that the FDA has approved the first clinical application of its pioneering
 technology to measure PAT (Peripheral Arterial Tone), a powerful signal which
 monitors peripheral vascular responses to autonomic nervous system activity.
 Clinical studies at leading institutions worldwide are demonstrating that
 analysis of the PAT Signal can provide clinicians with highly sensitive and
 accurate indicators to help identify, diagnose and monitor a variety of
 medical conditions. The FDA Class II approval announced today is for Itamar's
 ETT_PAT 2000 product, the first member of Itamar's Cardio_PAT line of devices,
 for use in ECG stress testing for the detection of myocardial ischemia.
     "Almost 20 million people have cardiac risk factors that may make them
 candidates for medical or surgical intervention and only 20-25% of them are
 being treated.  Many of these patients are at risk for future heart attack and
 often the ECG Stress Test is not sensitive enough to identify those at most
 risk," noted Alan Rozanski, MD, Professor of Medicine at Columbia University
 College of Physicians and Surgeons and a PAT investigator.  "In the FDA trial,
 use of PAT significantly increases the sensitivity of the Exercise Stress Test
 without loss of specificity.  The PAT represents a significant increase in our
 ability to diagnose disease accurately and possibly earlier, offering the
 opportunity to identify new populations of individuals who are candidates for
 more cost-effective early interventions."
     In studies with over 2,000 patients, the PAT increased the sensitivity of
 the exercise stress test by 30% without loss of specificity and reduced
 non-definitive tests by over 50%.
     The PAT signal accurately measures arterial pulsatile volume changes in
 the fingertip, which have been shown by Itamar to mirror changes or anomalies
 in autonomic nervous system activity and their related vascular events.  In
 the application of PAT technology whose approval is being announced today,
 easy-to-use, noninvasive finger mounted probes are used in conjunction with
 the ECG during standard exercise stress testing.
     "The PAT signal is an entirely new window into human physiology," said
 Barry L. Zaret, M.D., Professor of Medicine, Chief Section of Cardiovascular
 Medicine, Yale University School of Medicine and Medical Director, Yale New
 Haven- Heart Center. "Cardiovascular response to autonomic nervous system
 regulation can be independent of the patient's blood pressure, oxygen
 saturation or ECG changes. This approval opens the door to new ways of
 understanding and managing cardiovascular, respiratory and nervous system
 disorders with low-cost clinical applications that are more sensitive than our
 current tools."
     Itamar Medical has developed proprietary technologies, including
 non-invasive finger probes and advanced digital signal processing algorithms,
 to evaluate the PAT Signal in a number of important clinical applications
 including hypertension, myocardial ischemia, congestive heart failure,
 cardiovascular and peripheral vascular disorders, neurologic disorders, sleep
 medicine, and the early diagnosis of the vascular consequences of metabolic
 diseases like diabetes.  PAT-based technologies for screening, diagnostic,
 treatment assessment and follow-up are now undergoing evaluations in leading
 clinical centers at institutions worldwide including Columbia University,
 Harvard, Johns Hopkins, Mayo Foundation, Sahlgrenska University Hospital,
 Stanford, Tufts, and Yale.
     "This first regulatory approval both paves the way for the initial
 marketing and licensing of our PAT-based technology, and also serves as a
 testament to the strength of the basic research," states Israel Schreiber,
 President and Chief Executive Officer of Itamar Medical. "Itamar Medical is
 now uniquely poised to meet the diagnostic and follow up needs of the medical
 community by offering a family of safe, easy to use, non-invasive and highly
 sensitive additions to the physician's arsenal."
 
     About Itamar Medical
     Itamar Medical Ltd. is pioneering basic research into the autonomic
 nervous system integration of the cardiorespiratory and vascular systems.
 This basic research has resulted in the identification and development of the
 PAT (peripheral arterial tone) Signal -- a new physiologic signal with
 important implications for cardiology, and sleep medicine, as well as basic
 research in autonomic regulation of peripheral vasculature.  Itamar holds
 patents on the use of the PAT Signal for medical purposes and a growing body
 of proprietary technologies -- hardware, software, and signal processing
 algorithms -- to allow applications of the PAT signal in many areas of
 clinical medicine.  Itamar Medical, established in 1997, is headquartered in
 Caesarea, Israel and has received investment and technical support from global
 medical technology leader Medtronic Inc. To learn more about the PAT signal
 and Itamar Medical, visit http://www.itamar-medical.com.  For further
 information; email contact@itamar-medical.com, or phone 1-800-206-6952 (from
 the US only) or +972-4-617-7000.
 
 SOURCE  Itamar Medical