There may be a new player soon in the implantable device market after the FDA’s Circulatory System Devices panel voted 7 to 1 in favor of Cameron Health’s subcutaneous implantable cardioverter-difibrillator (S-ICD) system.
The panel’s decisions were based on results of a sponsor-launched prospective, non-randomized trial that looked at device complication. The majority of panelists agreed that the data demonstrated the safety and efficacy of the S-ICD system for the treatment of sudden cardiac arrest.
In December 2011, Cameron submitted a premarket approval application to the FDA based on data from a 33-patient investigational device exemption clinical study evaluating the safety and efficacy of the device.
In March, Boston Scientific announced that it intended to acquire Cameron for $300 million. The closing of the transaction is subject to customary conditions and is expected to occur in the second or third quarter of 2012, according to a statement from San Clemente, Calif.-based Cameron.