The FDA's Circulatory System Devices Panel will review Cameron Health's premarket approval application (PMA) for the S-ICD system (subcutaneous implantable cardioverter-defibrillator) on April 26.
“Our clinical data will demonstrate that the S-ICD system is a valuable new treatment option for patients at risk of sudden cardiac arrest,” said Kevin Hykes, president and CEO of the San Clemente, Calif.-based Cameron Health.
The FDA advisory panel will review clinical data on the safety and efficacy of the S-ICD system, including the results of a pivotal Investigational Device Exemption clinical study of 330 patients at risk of sudden cardiac arrest. The PMA was submitted to the FDA in December 2011.
On March 8, Boston Scientific of Natick, Mass., reported it would exercise its option to acquire Cameron Health. Closing of the transaction is subject to customary conditions, including relevant antitrust clearance, and is expected to occur in the second or third quarter of 2012.