This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Subcutaneous Implantable Defibrillator (S-ICD) System
PMA Applicant: Cameron Health, Inc.
Address: 905 Calle Amanecer, Suite 300, San Clemente, CA 92673
Approval Date: September 28, 2012
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf11/P110042a.pdf
What is it? The Subcutaneous Implantable Defibrillator (S-ICD) System is a defibrillator that is implanted under the skin (subcutaneous). It provides an electric shock to the heart (defibrillation) for the treatment of an abnormally rapid heartbeat that originates from the lower chambers of the heart (ventricular tachyarrhythmias). The S-ICD System consists of:
- a titanium case containing a battery and electronic circuitry that provides defibrillation therapy and pacing at a rate of 50 beats per minute up to 30 seconds after a shock
- a subcutaneous electrode which has a proximal and distal ring electrode on each side of a 3 inch (8 cm) defibrillation coil electrode.
- accessories include an electrode insertion tool, programmer, telemetry wand, magnet, suture sleeve, torque wrench, and memory card.
How does it work? The S-ICD (pulse generator) is implanted under the skin on the side of the chest below the arm pit. The pulse generator is connected to the electrode which is implanted under the skin from the device pocket along the rib margin to the breastbone with the use of the insertion tool.
The S-ICD monitors cardiac rhythms and delivers defibrillation when ventricular tachyarrhythmias are detected. After delivery of a shock, the S-ICD provides post-shock bradycardia pacing therapy when needed. The S-ICD is programmable as a single or dual zone device which allows the doctor to tailor the therapy for the patient.
When is it used? The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, continual (incessant) ventricular tachycardia, or spontaneous frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.
What will it accomplish? The S-ICD System is effective in providing an electrical shock to the heart to treat life-threatening arrhythmias. In the clinical studies, the S-ICD System was shown to be capable of restoring a normal and stable rhythm thereby supporting life. The subcutaneous lead also eliminates the risks associated with implanting leads on or in the heart (transvenous leads). In addition, the System meets an unmet need for patients who are not suitable for transvenous lead placement.
When should it not be used? The S-ICD System should not be used if patients have symptomatic bradycardia, incessant ventricular tachycardia which can be terminated with anti-tachycardia pacing, and/or patients who have unipolar pacemakers.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.
- FDA News Release
- NIH - MedlinePlus - Pacemakers and Implantable Defibrillators
- American Heart Association - Implantable Cardioverter Defibrillator