"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, Cameron Healths President and CEO.
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 SCA.
"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 Dr. Martin Burke, Professor of Medicine and clinical investigator from the University of Chicago.
In 2011, the FDA granted expedited review status for the S-ICD System PMA application.
About the S-ICD System
The S-ICD System is unique in that the implantation of the system is entirely subcutaneous, removing the need for lead placement inside the heart. Essentially, the S-ICD System eliminates the major risks associated with transvenous leads. The S-ICD System detects highly accelerated and disorganized heart rhythms caused by ventricular arrhythmias that can lead to sudden cardiac arrest. When abnormal arrhythmias are detected, the S-ICD System delivers an 80 Joule shock to restore the hearts normal rhythm. Left unaddressed, these disorganized heart rhythms are often fatal.
About Sudden Cardiac Arrest (SCA)
SCA is a sudden, abrupt loss of heart function. Most SCA episodes are caused by the rapid and/or chaotic activity of the heart known as Ventricular Tachycardia or Ventricular Fibrillation. Recent estimates show that approximately 850,000 people in the U.S. are at risk of SCA and indicated for an ICD device, but remain unprotected. In fact, less than 35 percent of patients who are indicated for an ICD receive one. SCA is not the same as a heart attack. A heart attack is a malfunction caused by blockage in a vessel that supplies blood to the heart, which may permanently damage part of the heart. Unlike SCA, most people survive a first heart attack. SCA is an "electrical" malfunction of the heart that results in no blood flow to the body or the brain. SCA is fatal if left untreated. ICDs are proven to be 98 percent effective in treating dangerous heart rhythms that can lead to SCA.
About Cameron Health, Inc.
Cameron Health, Inc. (www.cameronhealth.com), headquartered in San Clemente, California, is a pioneer in the development, manufacture and distribution of the next generation of implantable defibrillators.
Posted by Sean Fenske, Editor-in-Chief, MDT