Medtronic Inc. announces U.S. Food and Drug Administration (FDA) approval of its CardioSightTM Service, an in-clinic data access tool now available to physicians treating heart failure patients who have one of several Medtronic cardiac resynchronization therapy defibrillators (CRT-Ds) or implantable cardioverter-defibrillators (ICDs).
CardioSight Service provides clinically valuable, device-derived information applicable to the treatment of heart failure to help specialty physicians discern if the heart failure patient's symptoms are stable or deteriorating. For example, heart failure physicians following patients with a Medtronic InSync SentryTM CRT-D system can use CardioSight Service to track patient fluid levels in the thoracic cavity (chest and lungs) through the implantable device's innovative OptiVolTM Fluid Status Monitoring feature. By identifying and addressing heart failure symptoms more rapidly and effectively, physicians using the CardioSight Service may help prevent emergency treatment or hospitalizations.
"Currently, it's very challenging for heart failure physicians to reliably, efficiently and regularly monitor their patients' heart rhythm activity or lung fluid levels," says Randall C. Starling, MD, head, section of heart failure and cardiac transplant medicine department of cardiovascular medicine, Cleveland Clinic Foundation. "Symptom-driven, immediate access to this data will aid the heart failure team to optimize diagnosis and management of these symptoms. Information from CardioSight Service may enable us to pinpoint the reason for the patient's symptoms and provide effective treatment for heart failure patients with implanted devices."
CardioSight Service is a non-invasive, device information access system for in-clinic use by physicians who regularly care for heart failure patients with an implanted Medtronic device, but did not implant the cardiac device. It provides simple and timely access to information about a patient's physiological condition that previously was unavailable to physicians who don't implant devices or have access to a device programmer. This information would not be otherwise readily available to the physician without a formal evaluation of the device at a cardiology clinic.
At the touch of a button, data can be transmitted from the implantable device via the CardioSight Reader. By holding the Reader's antenna (similar size and shape of a computer mouse) over the implantable device, the physician can quickly collect and download 90 days of the patient's cardiac rhythm trends and patient activity patterns without a device programmer. A report of this information is available by fax within minutes after the data is collected.
"The ability to diagnose and manage changes in heart rhythm patterns and heart failure symptoms is an important innovation we believe will improve standards of patient care," says Steve Mahle, president of Medtronic Cardiac Rhythm Management. "Our devices can monitor and detect a wealth of clinical information, such as fluid buildup in the thoracic cavity with our new InSync Sentry system. By pairing these implantable devices with innovative information access solutions like CardioSight Service, we can help more physicians identify changes in a patient's condition and modify prescribed therapies, which in turn may reduce hospitalizations."
Reports generated by the CardioSight Service will give heart failure physicians an improved ability to:
-
Track intrathoracic fluid accumulation via OptiVol Fluid Status Monitoring that monitors fluid build-up in a patient's chest and lungs;
-
Corroborate patient symptoms;
-
Identify asymptomatic arrhythmias;
-
Evaluate the efficacy of arrhythmia treatments; and
-
Titrate drug dosages.
Afflicting five million Americans, heart failure is the leading cause of U.S. hospital admissions, with most due to fluid accumulation in the thoracic cavity. It is estimated that heart failure is responsible for $40 billion in direct and indirect healthcare costs in this country alone. The number of Americans with heart failure is expected to double in the next five years as the "Baby Boomer" population ages.
Source: Medtronic Inc.
