A meeting of the Circulatory System Devices Panel was held on March 1, 2007. The Panel discussed, made recommendations, and voted on a premarket approval application (P050032) for the Chronicle Implantable Hemodynamic Monitor (IHM) System.
The sponsor was seeking the following indications for use statement for the device: The Chronicle Implantable Hemodynamic Monitor (IHM) System is indicated for the chronic management of patients with moderate to advanced heart failure who are in NYHA Class III or IV to reduce hospitalizations for worsening heart failure in these patients.
The Chronicle Implantable Hemodynamic Monitor (IHM) combined with the Chronicle Pressure Sensing Lead measures and stores hemodynamic data, heart rate, activity, and temperature for the ambulatory patient. The patient also carries an external pressure reference, Chronicle Tracker, which corrects the intracardiac pressure data for any changes in the barometric pressure. The Chronicle IHM and Chronicle Tracker data can be obtained through the programmer (for in-office visits) or viewed on the web-based Medtronic CareLink Network. The patient uses the Medtronic CareLink Monitor for Chronicle Systems to send Chronicle IHM and Chronicle Tracker data via a phone line in their home to the Medtronic CareLink Network. The data are then stored on the secure Medtronic CareLink Network for clinician viewing. Use of the data will allow clinicians to assess a patient’s hemodynamic status, and make clinical decisions to better manage a patient’s heart failure.
The sponsor presented data from a randomized trial of 274 patients at 28 sites. Following presentations by the sponsor and the FDA, and after questioning the sponsor and deliberating, the Panel voted (9-2) in favor of Not Approvable. The panel cited concerns regarding lack of clinical effectiveness as the main reason for their recommendation.
Contact: James Swink, Executive Secretary,
(240) 276-4179 James.Swink@fda.hhs.gov
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