www.fdanews.com/articles/90704-fda-panel-votes-against-approval-for-medtronic-s-implantable-heart-diagnostic-device
FDA PANEL VOTES AGAINST APPROVAL FOR MEDTRONIC'S IMPLANTABLE HEART DIAGNOSTIC DEVICE
March 2, 2007
An advisory panel has recommended against FDA approval for Medtronic's Chronicle implantable hemodynamic monitor system until the firm can conduct a larger clinical trial.
The agency's Circulatory System Devices Advisory Panel made its recommendation by a vote of 9-2 March 1. The panel said the company's premarket approval application for the Chronicle did not meet the FDA's standard for demonstrating effectiveness.
The device is designed to continuously measure and record intra-cardiac pressure using a pressure-sensing lead that is threaded into the right ventricle of the heart to measure heart rate, temperature and activity.