Posts Tagged ‘CardioMEMS’

August 14th, 2014

The CardioMEMS HF System: What Do You Say to Your Patient?

In this scenario based on a patient’s question about the CardioMEMS device, John Ryan asks, “What do you say to your patient?”

October 10th, 2013

CardioMEMS Heart Failure Device Gets Mixed Reception From FDA Advisory Panel

The FDA’s Circulatory System Devices Panel sent a mixed message to the FDA today about the CardioMEMS Champion HF Pressure Measurement System.  The small implantable device provides daily pulmonary artery pressure measurements to guide physicians in their treatment of patients with congestive heart failure. In December 2011 the same panel voted 9-1 that the device was safe, 7-3 that the […]

December 22nd, 2011

A New Brave New World? Impact of Technology on Fellowship Training

Last week, CardioMEMS failed to get approval from an FDA advisory panel for treating heart failure based on uncertainty regarding the benefit;  the advisory panel also raised concerns about study bias. This intracardiac device measures pulmonary artery pressures that clinicians can use (in addition to other clinical signals, such as weight gain) to select therapies […]

December 9th, 2011

FDA Advisory Panel Votes Against Implantable CardioMEMS HF Pressure Measurement System

Members of the FDA Circulatory System Devices Panel on Thursday recommended against approval of the implantable CardioMEMS HF Pressure Measurement System. Although panel members agreed that the device was safe by a 9-1 vote, they voted 7-3 that the device had not been shown to be effective and 6-4 that the benefits did not outweigh the risks. […]

December 6th, 2011

FDA Reviewers Raise Questions About CardioMEMS CHAMPION Trial Ahead of Advisory Panel

FDA reviewers have raised serious questions about the results of the CHAMPION trial of the implantable CardioMEMS HF Pressure Measurement System (HF System), which provides daily pulmonary artery pressure measurements for the purpose of guiding heart failure treatment. On December 8, the FDA’s Circulatory System Devices Panel is scheduled to review the PMA for the device. (Click here […]

November 23rd, 2011

CardioMEMS CHAMPION Trial Undergoes Scrutiny From Wall Street Ahead of Next Month’s FDA Panel

Note to readers: An earlier version of this story stated that the FDA may be concerned about the conduct of the CHAMPION trial. This statement could be construed as an implication of ethical misconduct or negligence on the part of the trial sponsors or investigators. I apologize if I conveyed this impression in the earlier story. […]