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New Device Approval

Guidant Cardiac Resynchronization Therapy Defibrillators (COMPANION trial) - P010012/S026

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 CD, CONTAK CD2, RENEWAL, and RENEWAL 3 Cardiac Resynchronization Therapy Defibrillators
Manufacturer: Guidant Corporation
Address: 4100 Hamline Avenue North, St. Paul, MN 55112
Approval Date: September 14, 2004
Approval Letter: http://www.fda.gov/cdrh/pdf/P010012S026a.pdf

What is it? The Guidant CONTAK CD, CONTAK CD2, RENEWAL, and RENEWAL 3 are implantable cardioverter defibrillators (ICDs) that also deliver cardiac resynchronization therapy (CRT). These ICDs use small electrical impulses to coordinate heart rhythm and improve blood pumping ability in certain patients with moderate to severe heart failure.

How does it work? A Guidant Cardiac Resynchronization Therapy Defibrillator (CRT-D) consists of an implantable pulse generator (IPG), made up of a battery and electronic circuitry, connected to three leads (insulated wires). The IPG 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 heart chamber (the right ventricle), and
• a third lead is placed in a vein that overlies the left ventricle.

When the device is functioning as an ICD, it senses dangerous abnormal heart rhythms 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? A Guidant CRT-D is used in certain patients who have:

• symptoms of advanced heart failure despite taking heart failure medication, and
• a heart rhythm problem (arrhythmia) that may cause the lower chambers of the heart to beat in an uncoordinated manner.

A Guidant CRT-D is indicated for patients with moderate to severe heart failure (NYHA III/IV) who remain symptomatic despite stable, optimal heart failure drug therapy, and have left ventricular dysfunction (EF </= 35%) and QRS duration >/= 120 ms.

What will it accomplish? A Guidant CRT-D will deliver:

• CRT to help coordinate the beating of the heart, and
• a life-saving shock to attempt to return the heart to normal heart rhythm.

Together, these two therapies may reduce the combined risk of death or first hospitalization as well as the risk of death alone. It may also relieve some of the symptoms associated with heart failure, 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 are available at: http://www.fda.gov/cdrh/pdf/P010012S026.html

Other:

• Heart disease: http://www.fda.gov/hearthealth
• Heart failure: http://www.heartfailure.org/
     http://www.nhlbi.nih.gov/health/dci/Diseases/Hf/HF_WhatIs.html
• Arrhythmias: http://www.acc.org/media/patient/chd/cardiac%5Farrhythmias.htm

Updated September 24, 2004

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