CardioMEMS to press on despite FDA setback

  • Article by: JAMES WALSH , Star Tribune
  • Updated: December 9, 2011 - 9:12 PM

A panel gave a negative recommendation to a wireless device that allows cardiologists to monitor patients from their homes.

The chief executive of CardioMEMS said Friday that the company intends to keep moving forward despite a setback with the Food and Drug Administration over a new heart failure monitoring system.

The Atlanta-based company, which is partly owned by St. Jude Medical Inc. of Little Canada, received an unfavorable recommendation this week from a panel that reviewed its CardioMEMS Champion Heart Failure Monitoring System.

The device is an implantable, wireless device that allows cardiologists to monitor heart failure patients from their homes.

When asked if the technology is safe, the FDA's Circulatory Systems Devices advisory panel voted 9-1 in favor. But when asked if the device is effective, the panel voted 7-3 against. And the panel voted 6-4 against when asked if the device's benefits outweigh its risks.

The panel's recommendation is not binding, but the FDA often follows such recommendations when deciding whether to approve a new device.

"While we are disappointed with today's outcome, we look forward to continuing discussions with the FDA to determine the best path forward," said Dr. Jay Yadav, CardioMEMS CEO and founder. "We believe this technology is a significant step forward in the management of heart failure patients."

Analyst Rick Wise of Leerink Swann Research noted that the panel acknowledged that there seems to be a benefit for patients monitored by the device. He said he expects "a new approval pathway will be sought going forward."

St. Jude Medical owns 19 percent of CardioMEMS and plans to move toward full ownership of the company, depending on certain regulatory milestones. That deal remains in place.

James Walsh • 612-673-7428

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