CardioMEMS ran into a regulatory roadblock last week, when an FDA advisory panel recommended that the agency not approve the company's Champion HF Monitoring System. The device is said to be the first permanently implantable, wireless device for remote monitoring of patients with heart failure.
Though the FDA's Circulatory Systems Devices Panel voted 9-1 that the implantable monitor was safe, the committee ruled 7-3 that there was no reasonable assurance of the effectiveness of the device and 6-4 that risks outweighed potential benefits. The opinion is nonbinding, but the FDA generally follows the advice of its advisory panels.
"While we are disappointed with today's outcome, we look forward to continuing discussions with the FDA to determine the best path forward. We believe this technology is a significant step forward in the management of heart failure patients," CardioMEMS CEO and founder Dr. Jay Yadav, said in a statement from the company.
Atlanta-based CardioMEMS said that a clinical trial showed a 28 percent reduction in hospitalization rates for heart failure within six months of implantation and 37 percent lower hospitalization rates after 15 months, when compared to patients receiving standard treatment for the condition. The implanted Champion HF sensor measures pressure in the pulmonary artery, and sends readings wirelessly to an external receiver, which then transmits data to a secure CardioMEMS database that physicians can access.
According to MedPage Today, the FDA panel was concerned about a series of e-mails that may have biased the results. Physicians were supposed to receive automated alerts if the monitors found elevated pulmonary artery pressure in patients with the implanted devices. However, the FDA reportedly found that messages contained specific advice from CardioMEMS nurses and that some physicians received follow-up phone calls from the company. The committee was unable to determine if the benefits were the result of the device, the nursing support or a combination of the two factors.
The committee also questioned whether the device worked as well in women as in men, because there were not enough women in the study group to draw statistically significant conclusions, MedPage Today reported.
Reuters reported that the CardioMEMS device would have a market potential of $1 billion as the only standalone, implantable device for diagnosing heart failure in the U.S. Foreign sales could account for as much as $2 billion more. St. Jude Medical holds a 19 percent stake in CardioMEMS, plus an option to purchase the company outright.