Cameron Health (San Clemente, CA), which was purchased in March by Boston Scientific, is reporting that the FDA’s Circulatory System Devices Panel has recommended approval for its S-ICD system, an implantable defibrillator that unlike traditional ones does not use intracardiac leads. Instead, an electrode implanted vertically under the skin on the chest senses the heart’s electrical signals and corrects them with appropriate shocks.
Though the recommendation for approval points to a likely final clearance of the device by the US FDA, the latest study of the S-ICD system did show it generates more unnecessary shocks, leads to more infections, and loses battery life faster than traditional ICDs. According to Bloomberg wire’s Apr 23, 2012 article, “Cameron Health also is working with the FDA to understand the root cause of premature battery depletion in the device. The FDA won’t consider approval until the issue is resolved, according to the report. The panel won’t weigh the battery issue.”
The S-ICD system has already been approved in the European Union for the last three years.
Here’s an animation demonstrating the implantation of the S-ICD:
Product page: S-ICD System…