FDA Panel Rejects Medtronic Remote Monitoring System

In what some industry observers saw as a setback for at-home patient monitoring, FDA's Circulatory System Devices Panel rejected the premarket approval application (PMA) for the Chronicle implantable hemodynamic monitor system, manufactured by Medtronic Inc. (Minneapolis). The pacemaker-sized device is implanted in the upper chest and is attached to a sensor located in the heart's right ventricle. Chronicle is part of a comprehensive, real-time information system, which continuously measures and stores data on heart rate, pressure in the heart, body temperature, and the activity level of patients with heart failure.

The clinical data is downloaded by the patient by moving a wand-like device over the upper chest. Using a special modem connection, the data is transmitted to a doctor or hospital where any indicators of a potential problem would alert the healthcare provider to make adjustments to patient care through medication, diet, and other changes. If the submitted data suggests a more serious condition, the patient would be advised to seek immediate medical attention.

Medtronic began clinical trials of the device in 2003. Two years later, the findings were presented at the annual scientific session of the American College of Cardiology (ACC; Washington, DC). In the Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure (COMPASS-HF) study, the device performed safely and reliably with no failures or system-related complications.

Commenting on the clinical trial at the March 2005 ACC meeting, Robert Bourge, MD, director of the division of cardiovascular disease at the University of Alabama at Birmingham and lead investigator, said, "These results demonstrate the benefits of remotely monitoring hemodynamics and congestion in many heart failure patients using an implantable monitor. Currently, physicians have no reliable, efficient way to measure this information."

In the trial, the endpoint for clinical efficacy was Chronicle's purported ability to reduce the number of hospitalizations or visits to emergency rooms or other urgent-care centers. While use of the device was shown to result in a 22% reduction in such incidents, the findings were not statistically significant when compared with the outcomes of a similar group of patients who were not implanted with the device.

Following the results of the clinical trial reported at the ACC meeting, Steve Mahle, president of Medtronic's cardiac rhythm management division, said the use of implantable hemodynamic monitoring could alert clinicians to early signs of deteriorating heart function and enable them to tailor medical therapy to improve the patient's condition. "Every cardiologist knows the difficulty of keeping hard-to-manage heart failure patients out of the hospital. We are optimistic that the Chronicle device will soon move beyond investigational use for the benefit of many heart failure patients."

Citing the statistically insignificant results as "lack of clinical effectiveness," however, the FDA panel rejected Medtronic's application in a 9-2 vote. Additionally, panel members reportedly expressed concern about the size of the clinical trial, which included 274 patients in eight clinical settings.

Responding to the panel's decision, David Steinhaus, MD, vice president and medical director of Medtronic's cardiac rhythm disease management division, said, "We continue to believe in the benefit of this sound technology and intend to work in close collaboration with the FDA to define the appropriate path for approval."

In contrast to some reports in the business and general press, most medtech analysts did not view the panel's ruling as a serious setback--either for Medtronic's Chronicle or for other at-home heart monitoring devices currently in development or undergoing clinical trials.

Thomas Gunderson, a managing director and senior medtech analyst at Piper Jaffray & Co. (Minneapolis) said the panel's decision was only a mild surprise. "Chronicle is an invasive implant, and the panel simply saw the device as not meeting the established endpoint of significantly reducing hospitalizations or other emergency interventions. Overall, it's only a mild setback for Medtronic. The company is making serious headway with this technology. Their ultimate goal is to market their pacemakers and implantable cardioverter-defibrillators (ICDs) with sophisticated on-board patient monitoring."

Medtronic is currently conducting clinical trials of a new defibrillator that incorporates Chronicle's heart monitoring technology.

Other companies developing remote monitoring devices for heart patients include St. Jude Medical Inc. (St.Paul, MN), Boston Scientific Corp. (Natick, MA), and Remon Medical Technologies Inc. (Waltham, MA).

© 2007 Canon Communications LLC

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