Cameron Health’s Subcutaneous ICD Scheduled for FDA Panel Review in April
March 19, 2012 - Cameron Health Inc. announced today that the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel will review the premarket approval (PMA) application of the S-ICD (Subcutaneous-Implantable Cardioverter Defibrillator) system April 26, 2012.
“The FDA advisory committee meeting represents a significant step towards obtaining U.S. approval of the S-ICD System,” said Kevin Hykes, Cameron Health’s president and CEO. “We look forward to the opportunity to discuss the safety and efficacy of the S-ICD system with the FDA review team. Our clinical data will demonstrate that the S-ICD System is a valuable new treatment option for patients at risk of sudden cardiac arrest.”
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 (IDE) clinical study of 330 patients at risk of SCA. The PMA application was submitted to the FDA in December 2011.
On March 8, Boston Scientific Corp. announced that it would exercise its option to acquire Cameron Health Inc. 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.
To see a video of how the system is implanted, click here.
For more information: www.cameronhealth.com