Bloomberg updates us with regard to the Atricure’s FDA Panel Review Meeting on Wednesday:
“If this device gets out of the back alleys and into the light in terms of education, then my feeling is we’ll see a better safety profile”: Panel Member
The benefits of AtriCure Inc. (ATRC)’s device to treat atrial fibrillation during open-heart surgery outweigh the risks, advisers to U.S. regulators said.
An advisory panel to the Food and Drug Administration today voted 5-3 with one abstention to recommend the device system for patients with a certain type of the condition known as atrial fibrillation. The agency isn’t required to follow the panel’s advice.
The panel also voted 5-4 with one abstention that the so- called ablation device from West Chester, Ohio-based AtriCure is safe and 9-0 that it is effective to treat persistent irregular heartbeat. The instrument system didn’t appear to meet safety and effectiveness goals when considering the least healthy patients, FDA staff said in a report Oct. 24.
“If this device gets out of the back alleys and into the light in terms of education, then my feeling is we’ll see a better safety profile,” said Robert Jaquiss, a panel member and chief of pediatric cardiothoracic surgery at Duke University Medical Center in Durham, North Carolina.
AtriCure’s device already is approved to destroy heart tissue during surgery. The company is seeking to expand its use to block electrical signals and restore a regular heartbeat as an alternative to therapies such as pacemakers or electrical cardioversion, an electric shock delivered to the chest wall.
For the full article click this link