Boston Scientific Cardiac Resynchronization Therapy Defibrillators - P010012/S230
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: LIVIAN®, COGNIS® and CONTAK RENEWAL® 3 RF Cardiac Resynchronization Therapy Defibrillators
PMA Applicant: Boston Scientific
Address: 4100 Hamline Avenue North, St. Paul, MN 55112
Approval Date: September 16, 2010
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/p010012s230a.pdf
What is it? The Boston Scientific LIVIAN, COGNIS, and CONTAK RENEWAL 3 RF Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices are implantable cardioverter defibrillators (ICDs) that also deliver cardiac resynchronization therapy (CRT). These CRT-Ds use small electrical impulses to coordinate heart rhythm and improve blood pumping ability in certain patients with heart failure.
How does it work? The CRT-D system consists of an implantable pulse generator, made up of a battery and electronic circuitry, connected to three insulated wires (leads). The pulse generator is usually implanted below the collarbone, just beneath the skin. The leads are placed in three different areas:
- One lead is placed in an upper heart chamber (the right atrium)
- A second lead is placed in a lower right heart chamber (the right ventricle)
- A third lead is placed in a coronary vein on the outer surface of the lower left heart chamber (the left ventricle)
When the device is functioning as an ICD, it senses dangerous abnormal heart rhythms (arrhythmias) and attempts to shock the heart back into a normal rhythm. The CRT portion of the device coordinates the beating of the left and right ventricles so that they work together more effectively to pump blood throughout the body.
When is it used? TheBoston Scientific CRT-D is used in certain patients who have:
- Risk of an abnormal heart rhythm problem that may cause the lower chambers of the heart to beat in an uncoordinated manner, and
- Heart failure despite taking heart failure medications.
Boston Scientific CRT-Ds are used in patients with heart failure who receive stable optimal prescription drug therapy for heart failure and who meet any one of the following classifications:
- Moderate to severe heart failure (New York Heart Association [NYHA] Class III-IV) with ejection fraction (*EF) equal or less than 35% and (**QRS) duration equal or greater than120 milliseconds (ms)
- Left bundle branch block with QRS equal or greater than 130 ms, EF equal or less than 30%, and mild (NYHA Class II) ischemic or non-ischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure
* Ejection fraction is the fraction of blood pumped out of ventricles with each heart beat.
** QRS is a name for some of the signals seen on a typical electrocardiogram, which is a picture of the electrical activity of the heart.
What will it accomplish? Together, the cardiac resynchronization therapy and the defibrillation therapy will:
- Deliver a lifesaving shock to attempt to return the heart to normal rhythm.
- Help coordinate the beating of the heart.
- Reduce the patient's risk of death or going to the hospital for heart failure.
- Improve the patient’s ability to engage in physical activity.
- Relieve some of the symptoms associated with heart failure in moderate to severe heart failure patients, including shortness of breath and fatigue during exercise, which may result in a better quality of life.
When should it not be used? There are no contraindications for this device.
Additional information : Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cftopic/pma/pma.cfm?num=p010012s230
Other Resources :
Heart Failure and Disease:
Implantable Cardioverter Defibrillators:
Cardiac Resynchronization Therapy: