A U.S. Food and Drug Administration advisory panel has voted against approving an implantable device that monitors patients for signs of heart failure made by CardioMems Inc.

The advisers, a committee of experts outside of the FDA, believe that the benefits don’t outweigh its risks. Six out of 10 members voted against the wireless pressure sensor and its computer monitors, on Thursday in Gaithersburg, Maryland.

However, the members agreed that the device was safe by a 9 to 1 vote.

The committee’s decision will help influence a final FDA decision for approval to make the device for sale in the marketplace. The FDA is not required to follow the committee’s recommendations.

The decision was based on the CHAMPION clinical trial study sponsored by the Atlanta-based company. The results of the trial showed significant results for its primary efficacy and safety end points in patients who had treatment adjustments because of the device.

The trial indicated that the device would significantly drop risks of heart-failure-related hospitalizations over a six month period. The trial also showed no important device related complications, according to a CardioMEMS statement released Thursday.

However the committee said that the design of the trial made it difficult to distinguish the treatment effect of the device from the overall care patients received from clinicians who knew which patients had the device.

"Everybody believes something good happened here, but we can't say why," said panel chairman Dr. Jeffrey Borer, according to Reuters.

"We can't tell you the device was critically important" to the study's results, Borer added, according to heartwire.

The decision from the panel marks the beginning of an uphill battle for both CardioMems and St. Jude Medical Inc.

St. Jude had preciously invested $60 million 2010 to gain a 19 percent stake to acquire CardioMems with an exclusive $375 million buyout clause.

"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," Jay Yadav, CardioMEMS CEO and Founder said in a statement on Thursday.