The FDA’s Circulatory Systems Devices Panel voted today to reject approval of Medtronic’s Chronicle Implantable Hemodynamic Monitor. Although the vote is non-binding, the agency will most likely follow the panel’s guidance.
The device is intended to measure a patient’s vital signs and deliver the information in downloadable form directly to computers in doctors’ offices. However, a clinical trial of the device, known as the COMPASS-HF study, found the technology not to be as effective as advertised and that implantation of the device in seriously ill patients increased the risk of fatality.
The study showed that the device resulted in a 21 percent reduction in heart-failure-related hospital visits in the first six months, but FDA panelists said the number was “not statistically significant.†In addition, the FDA said that although mortality rates were unaffected within the first six months, the “survival curves separate†after that, especially among those with severe heart conditions.
Earlier this year, the FDA announced that it had concluded an investigation into the safety of Medtronic’s Concerto defibrillator and found no evidence of safety issues. The Concerto CRT-D device was approved by the FDA in May of last year and uses what’s called “wireless telemetry†technology, which allows physicians to remotely monitor a patient’s vital signs, as well as data about the defibrillator’s performance.
A former Medtronic engineer, Christopher Fuller, was concerned about the stability of the high-frequency signal that the device uses to communicate this information and he alerted the FDA to the potential safety concerns. (He resigned from Medtronic in December of 2005, largely because of these concerns.)
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