Cameron Health announced that it has submitted the premarket approval (PMA) application to the Food and Drug Administration (FDA) for the S-ICD system, the world’s only completely subcutaneous implantable defibrillator.
The PMA submission included data from a 330-patient pivotal IDE clinical study which evaluated the safety and efficacy of the S-ICD system in patients at risk of sudden cardiac death.
“The S-ICD system avoids placement of leads or electrodes inside the heart. This has the potential to eliminate many of the serious complications related to traditional transvenous leads and represents an important alternative for many patients,” said Martin Burke, professor of medicine and clinical investigator from the University of Chicago, USA.
“This is an important milestone for our company. We look forward to working closely with the FDA through the review process to make this important technology available to more patients at risk of sudden cardiac arrest,” said Kevin Hykes, president and CEO, Cameron Health.
In 2011, the FDA granted expedited review status for the S-ICD system PMA application.