Remote Heart Monitors - Telemedicine in the News

 

The Food and Drug Administration's rejection of Medtronic's remote heart monitor has been big news - probably because it was reported in the "newspaper of record", the New York Times.

According to the report:

Medicine's march toward remote monitoring of patients hit at least a temporary roadblock yesterday.

An implanted wireless device intended to continuously monitor patients with weak hearts — and then provide the data to doctors via the Internet — did not keep enough of them out of the hospital to prove its effectiveness, according to a panel of experts assembled by the Food and Drug Administration.

The device's manufacturer, Medtronic, has been developing wireless data-gathering technology for implanted therapeutic devices like defibrillators and insulin pumps. It aimed to make the product reviewed yesterday, a device the size of a pocket watch and known as the Chronicle implantable hemodynamic monitor, the first major implant approved solely for diagnostic monitoring.

The Chronicle monitors blood pressure and other conditions inside the hearts of patients suffering heart failure, a disease that reduces the amount of blood the heart pumps. The goal is to warn patients, their doctors and other people who care for them when they are in danger at a point before they need to be hospitalized.

In 2005, Medtronic had reported promising test results, commenting:

Medtronic is dedicated to finding new ways to help improve the management of heart failure, and COMPASS-HF shows that with implantable hemodynamic monitoring clinicians can be alerted to early signs of heart failure deterioration and proactively tailor medical therapy to improve the patient’s condition. We are optimistic that the Chronicle device will soon move beyond investigational use for the benefit of many heart failure patients.

You can read more at A Hearty Life and in an AP report.

Other companies with remote heart monitor systems include St Jude Medical, CardioNet and Cardiac Telecom Corporation.

March 5th, 2007