FDA Panel Ambivalent on CardioMEMS Heart Failure Device

In 2012, CardioMEMS Inc. received a not approvable (NOAP) letter from the U.S. Food and Drug Administration (FDA) regarding its Champion HF (heart failure) Monitoring System. This week, after follow up actions taken by the company, an agency panel agreed that while the device was safe and its benefits outweigh its risks, its effectiveness is still not clear.

The  2012 NOAP letter asked CardioMEMS to provide additional data than was forthcoming from the device trial to demonstrate that there is a reasonable assurance of effectiveness; and to provide a full explanation as to why there was a large discrepancy in device effectiveness in men versus women (the device seemed to be more effective in men).

The FDA also requested that CardioMEMS hire an external auditor to identify and verify all nurse communications between the company and the investigative sites, as the agency became aware that nurses were contacting physicians to make medical therapy recommendations for some patients in the treatment group. Some advisory panel members said this created doubt as to whether the positive results in the treatment group could be attributed to the monitoring system or to the support system.

In response, CardioMEMS developed a model to determine the influence of nurse communications on patient outcomes; and carried out an ancillary subgroup analysis based on gender as an amendment to the original analysis.

In their second examination of the trial results, the FDA’s Circulatory System Devices Advisory Panel arrived at an ambivalent conclusion. No new safety data was presented to change the assessment of the safety profile of the device, which in 2011 was voted safe for its intended use. The new panel voted 11-0 that the device is safe, 7-4 that it is not effective and 6-4-1 that its benefits outweigh its risks.

“I believe the analysis and the data are not valid or convincing,” panel member David Milan, M.D., who voted no on effectiveness and risk/benefit, said. “The appropriate approach to take was following the FDA’s original recommendation of a properly performed randomized clinical trial.”

Valluvan Jeevanandam, M.D., who voted yes to all three questions, said that despite the flaws in the data, the device is “an excellent diagnostic tool, and there is an innumerable number of HF patients that I’d love to put it in.”

The panel agreed that should the FDA approve the device, there should be a post-approval study that addresses certain concerns, most notably that the device seems to be very minimally effective in women. Panelist Panelist Jeffrey S. Boyer, M.D., said that if it has been an option, he would have voted the device be indicated only for men pending post-approval trial results.

The CardioMEMS HF Pressure Measurement System is designed to gather information about a person’s heart wirelessly. It uses electronics customized to receive information from a sensor that is implanted into the pulmonary artery. The sensor does not have a battery or leads and is very small.

The FDA is not mandated to follow panel recommendations, but it usually does.

CardioMEMS is a medical device company that is developing a proprietary wireless sensing and communication technology for the human body. The company is based in Atlanta, Ga.