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
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Product Name: Phylax AV Implantable Cardioverter
Defibrillator System & Programmer Software
Manufacturer: BIOTRONIK GmbH & Co.
Address: Woermannkehre 1, Berlin, Germany
Approval Date: September 29, 2000
Approval Letter: http://www.fda.gov/cdrh/pdf/p000009a.pdf
What is it? A dual chamber Implantable Cardioverter
Defibrillator (ICD) with programmer software.
How does it work? The ICD is an implantable
electronic device built inside a metal (titanium) shell that is placed
under the skin in the shoulder area. The ICD is connected to standard ICD
leads (wires) that have been inserted through a vein into the heart.
Inside the ICD are a battery and a small computer that monitors heart
function. The ICD continuously monitors heart rhythms through the
implanted leads and responds when it detects an abnormal rhythm, such as a
ventricular tachyarrhythmia, which causes the heart to beat too fast
and/or irregularly. The ICD's response can give low energy electrical
stimulation or pulses that control pacing of the heart or high energy
defibrillation shocks that will be felt by the patient. This response by
the ICD is therapy delivered to the heart in order to return the heart to
a normal rhythm. The ICD also provides therapy when the heart rhythm is
too slow (bradycardia), in either one or two of the heart’s chambers
(atrium and/or ventricle).
When is it used? The Phylax AV is used for
patients who are at high risk of sudden death due to abnormal rhythms in
the ventricle and have experienced one or more of the following
- survival of at least one episode of cardiac arrest with a loss of
consciousness due to a ventricular tachyarrhythmia
- recurrent, poorly tolerated abnormally fast beating of the
ventricular chamber of the heart (ventricular tachycardia or VT)
What will it accomplish? When patients receive
therapy (electric stimulus) from the Phylax AV ICD, their abnormal heart
rhythm will be converted back to a normal heart rhythm.
When should it not be used? The Phylax AV should not
be used for patients whose ventricular tachyarrhythmias may have temporary
or reversible causes or when their ventricular arrhythmias are not
treatable with electrical therapy. The ICD should not be used for patients
who have a unipolar or single lead pacemaker, or for patients whose only
disorders are slow heart rates (bradyarrhythmia) or atrial arrhythmias. In
addition, patients with long-term refractory atrial tachyarrhythmias who
require both atrial and ventricular (dual chamber) pacing, are not
candidates for the Phylax AV.
Additional information: Summary of Safety and
Effectiveness and labeling are available at: http://www.fda.gov/cdrh/pdf/p000009.html