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New Device Approval

St. Jude Medical Frontier™ Biventricular Cardiac Pacing System

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: St. Jude Frontier™ Biventricular Cardiac Pacing System includes the Frontier™ Model 5508 and 5508L Pulse Generators and the Aescula™ LV Model 1055K Lead.
Applicant: St. Jude Medical
Address: 15900 Valley View Court, Sylmar, CA, 91342
Approval Date: May 13, 2004
Approval Letter: http://www.fda.gov/cdrh/pdf4/p030023a.pdf

What is it? The Frontier™ Biventricular Pacing System is used to maintain simultaneous contraction of the lower chambers of the heart (left and right ventricles) following an AV nodal ablation for irregular heart rhythm (chronic atrial fibrillation).

The device is made up of two parts:

• a pulse generator containing a battery and electronic circuitry, and
• three insulated lead wires that connect to the pulse generator.

How does it work? The Frontier™ System works by sending electrical impulses from a pulse generator through lead wires placed in three chambers of the heart. One lead is placed in the upper right chamber (right atrium) and the two other leads are placed in the lower chambers. The electrical impulses help the lower chambers contract simultaneously.

When is it used? The Frontier™ System should only be used to maintain simultaneous contraction of the lower heart chambers in patients who:

• have undergone an AV nodal ablation for chronic atrial fibrillation, and
• have mild to moderate heart failure.

What will it accomplish? The Frontier™ System improves exercise performance in patients who:

• have had an AV nodal ablation, and
• have mild to moderate heart failure.

When should it not be used? The Frontier™ System should not be used in patients who:

• have an implantable cardioverter-defibrillator (ICD),
• are unable to undergo an emergent open chest surgery, or
• have heart veins preventing the placement of the leads.

Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf4/p030035.html

• An anatomical diagram of the heart:
  http://www.nlm.nih.gov/medlineplus/ency/imagepages/1056.htm
• Information on heart diseases:
  http://www.nlm.nih.gov/medlineplus/heartdiseases.html
• Information on cardiac ablation:
  http://www.hrspatients.org/patients/treatments/cardiac_ablation.asp
• Information on pacemakers and implantable defibrillators:
  http://www.nlm.nih.gov/medlineplus/pacemakersandimplantabledefibrillators.html

Updated August 23, 2004

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