FDA PANEL: LARGER STUDY NEEDED ON IMPLANTABLE HEART DIAGNOSTIC DEVICE

An advisory panel has recommended against FDA approval for an implantable heart-monitoring device until the sponsoring firm can conduct a larger trial.

Citing a clinical study showing safety but not effectiveness, the Circulatory System Devices Advisory Panel made its recommendation by a vote of 9-2 regarding the premarket approval application for Medtronic's Chronicle implantable hemodynamic monitor system.

Medtronic presented results from its COMPASS-HF study, which was initiated in 2003 and included 274 patients grouped into two categories representing different levels of heart failure.

All patients were implanted with the Chronicle. They were randomized based on whether their physicians did or did not have access to the diagnostic data recorded by the Chronicle.

In arriving at its recommendation, the panel concluded that the primary effectiveness endpoint had not been met, although some panelists said the device might be effective at measuring pressure in the heart's capillaries.

( http://www.fdanews.com/ddl/34_10/ )