Heart Failure Monitor Device Fails with FDA

In a disappointing decision today, the FDA advisory panel failed to approve the Chronicle implantable hemodynamic monitor on the basis that it wasn't effective at helping to manage congestive heart failure:

(AP) — Federal health advisers recommended Thursday that the government not approve a novel implantable device designed to detect worsening heart failure.

The recommendation to the Food and Drug Administration against the Chronicle Implantable Hemodynamic Monitor came on a 9-2 vote. The FDA isn't required to follow its advisory committees' advice, but it does so most of the time.

A study of the device, made by Medtronic Inc., suggested it isn't effective.

This is a significant blow to the company who had visions of placing this pressure sensor on defibrillator leads in patients with congestive heart failure. Additional trials in patients with severe heart failure might be forthcoming, but unless other trials demonstrate that such monitoring can affect care, it is unlikely insurers will pay for the technology, especially in light of the current concerns over health care costs.