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New Device Approval

CONTAK RENEWAL® 3 AVT® Models M150, M155, M157 and M159 - P010012/S037

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: CONTAK RENEWAL® 3 AVT® Cardiac Resynchronization Defibrillator (CRT-D), Models M150, M155, M157, and M159
PMA Applicant:Guidant Corporation, a Boston Scientific Company
Address: 4100 Hamline Ave North , St. Paul, MN 55112
Approval Date: March 13, 2008
Approval Letter: http://www.fda.gov/cdrh/pdf/p010012s037a.pdf

What is it? The CONTAK RENEWAL® 3 AVT CRT-D® is an implantable cardioverter defibrillator (ICD) that also delivers cardiac resynchronization therapy (CRT) and atrial therapies.

How does it work? The CONTAK RENEWAL® 3 AVT CRT-D® consists of an implantable pulse generator (IPG), 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:

When the device is functioning as an ICD, it senses dangerous abnormal heart rhythms and shocks the heart back into a normal rhythm. The CRT portion of the device uses small electrical impulses to coordinate the beating of the left and right ventricles so that they work together more effectively to pump blood throughout the body. The atrial therapy portion of the device detects and treats rapid heart rates in the atrium with antitachycardia pacing or shock therapy.

When is it used? CONTAK RENEWAL® 3 AVT® is used in certain patients who have:

CONTAK RENEWAL® 3 AVT® CRT-Ds are indicated for patients with moderated 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.

CONTAK RENEWAL® 3 AVT® provides atrial antitachycardia pacing and atrial defibrillation treatment for patients with a history of, or who are at risk of developing atrial arrhythmias.

What will it accomplish? CONTAK RENEWAL® 3 AVT® will deliver:

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.

CONTAK RENEWAL® 3 AVT® will also deliver:

When should it not be used? There is no contraindication for this device.

Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf/p010012s037.html

Other:

ICD Information from FDA’s Heart Health Online Website
http://www.fda.gov/hearthealth/treatments/medicaldevices/icd.html

ICD Information from the National Library of Medicine’s Medline Plus
http://www.nlm.nih.gov/medlineplus/ency/article/007202.htm

CRT Information from Medline Plus
http://www.nlm.nih.gov/medlineplus/ency/article/007070.htm

Updated April 11, 2008

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