A U.S. Food and Drug Administration (FDA) panel has backed a new type of implantable heart defibrillator, but before the medical device gets full approval, other concerns will need to be addressed.
What is new about the device — developed by Cameron Health Inc. — is that it is implanted underneath the skin and does not touch the heart, reports Jennifer Corbett Dooren of The Wall Street Journal. Currently, other implantable defibrillators require thin, insulated wires to pass through blood vessels and into the heart.
The FDA’s Circulatory System Devices Panel, made up of non-FDA medical experts, voted 7-1 when asked the question as to whether the device was safe. Also, the panel voted 7-1 when asked whether the benefits of the device outweighed the risks. Both votes amounted to a recommendation that the agency approve the medical device. The panel said that the device represents an additional treatment option for people who are at risk of sudden cardiac arrest from an abnormal heartbeat.
However, the agency said it would not approve the device until concerns about its battery life are completely addressed. The FDA also was concerned about infections and the number of “inappropriate” shocks delivered to the heart, which can hurt patients and drain the battery too quickly. The agency did say, however, that the device’s elimination of the lead wire into the heart was its “primary benefit.”
A clinical study for the defibrillator enrolled 330 patients, and exceeded agency effectiveness and safety goals. However, the agency said that the safety goal did not include all device complications such as 18 infections, four of which required the device to be removed.
Dale McGeehon has been a journalist and editor for more than 25 years, covering chemical regulation and testing for Pesticides and Toxic Chemical News and innovations in material sciences for the National Technology Transfer Center. His writing credits include Omni and College Park magazines and The New York Times.