The US Food and Drug Administration (FDA) Circulatory System Devices Panel will review Cameron Health’s subcutaneous implantable defibrillator (S-ICD) system’s premarket approval (PMA) application on 26 April 2012.
As per the announcement, the FDA advisory panel will review clinical data of the S-ICD system, including the results of a pivotal investigational device exemption (IDE) clinical study.
The single-arm, multicentre, prospective IDE study application submitted to the FDA included 330 subjects and was designed to assess safety and efficacy of the S-ICD system, with primary clinical endpoints of arrhythmia conversion efficacy and complication free rate at six months for patients at risk of sudden cardiac arrest (SCA).
The PMA application, including IDE study data, was submitted to the FDA in December 2011. Cameron Health president and CEO Kevin Hykes said the FDA advisory committee meeting represents a step towards obtaining US approval for the S-ICD system.
"We look forward to the opportunity to discuss the safety and efficacy of the S-ICD system with the FDA review team," Hykes added.
"Our clinical data will demonstrate that the S-ICD system is a valuable new treatment option for patients at risk of SCA."
The S-ICD system is a minimally invasive device which detects disorganised heart rhythms caused by ventricular arrhythmias and delivers an 80 joule shock to restore the heart’s normal rhythm.
