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 and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: CONTAK® RENEWAL™ TR Models H120 and H125
Applicant: Guidant Corporation
Address: 4100 Hamline Avenue North
St. Paul, Minnesota 55112-5798
Approval Date: January 26, 2004
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030005a.pdf
What is it? The CONTAK® RENEWAL™ TR system is an implantable pulse generator (IPG) that delivers cardiac resynchronization therapy (CRT). The CRT portion of this device uses small electrical pulses to coordinate the heartbeat and improve blood pumping ability in certain patients with moderate to severe heart failure.
How does it work? The CONTAK® RENEWAL™ TR system consists of an IPG that is made up of a battery and electronic circuitry connected to three independent leads (insulated wires). The IPG is usually implanted below the collarbone, just beneath the skin. The leads are placed in three different areas:
- one in an upper heart chamber (the right atrium),
- a second in a lower heart chamber (the right ventricle), and
- a third in a vein that overlies the left ventricle.
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? The CONTAK® RENEWAL™ TR system is used in certain patients who have:
- an electrical disturbance resulting in an irregular heart beat (arrhythmia), and
- moderate to severe heart failure that is not successfully treated with medication.
Symptoms of heart failure such as fatigue, shortness of breath and difficulty performing daily activities are caused by the heart not pumping enough blood to meet the body's needs. In some heart failure patients the lower heart chambers do not contract together and CRT helps coordinate the heartbeat.
What will it accomplish? The CONTAK® RENEWAL™ TR system may result in a better quality of life for the patient by:
- improving the patient’s ability to engage in physical activity, and
- relieving some of the symptoms associated with heart failure including shortness of breath and fatigue during exercise.
When should it not be used? The CONTAK® RENEWAL™ TR system should not be used in patients who:
- have heart failure that is reversible or temporary,
- have not taken heart failure medication long enough to assess clinical improvement, or
- have a separate implanted cardioverter-defibrillator.
Summary of Safety and Effectiveness and labeling is available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p030005