| Atrial fibrillation is the most commonly encountered
arrhythmia after cardiac revascularization and valve
replacements, typically occurring in the first few
postoperative days. The development of postoperative atrial
fibrillation is associated with prolonged hospitalization,
higher costs, and increased morbidity. Pharmacological therapy
has been the treatment of choice to date, in which the
response has typically been unpredictable and carries the risk
of severe side effects and proarrhythmias.
There is an alternative to the present therapies; the ALERT®
TD System. This system includes the ALERT®TD
Catheter and the specifically designed ALERT® Companion
II. It provides the powerful capability of not only converting
atrial fibrillation to normal sinus rhythm through the
internal delivery of low energy electrical impulses with
ventricular synchronization but also measures hemodynamic
pressures. Blood samples may also be taken, and through the
use of a thermistor system, cardiac outputs can also be
measured. Programmable temporary atrial or ventricular
bradycardia pacing and sensing is also provided as well as
delivery of stimuli to terminate atrial tachyarrhythmias.
Configuration
The uniquely designed ALERT® TD Catheter is a
single multi-purpose, balloon-tipped catheter that has two
primary electrode arrays which are typically positioned in the
right atrium and the pulmonary artery, creating the pathway
for delivery of the internal cardioversion output energy. A
third electrode positioned in the right ventricle provides the
ventricular pacing and sensing functions as well as
ventricular synchronization, and an isolated electrode in the
atrial array provides the atrial pacing and sensing. Catheter
positioning can easily be accomplished from the IVC or the
SVC. The catheter is configured with a thermistor connector
that interfaces with most market-available cardiac output
computers. The ALERT® TD Catheter is easily
connected to the ALERT® Companion II through the
use of an interface cable. The ALERT® Companion II
is a compact, lightweight portable system with easy-to-use
software through its Pentium®-equipped touchscreen
computer. It is the energy source for the cardioversion
therapy as well as providing the pacing output function. In
the event of severe bradycardia, post-cardioversion, back-up
pacing as well as emergency VOO pacing is available.
Indications, contraindications,
warnings and instructions for use can be found in
the product labeling supplied with each product.
Patients should contact their physician for more
information about the product.
CAUTION: FEDERAL LAW (USA)
RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER
OF A PHYSICIAN. FOR SINGLE USE ONLY. The ALERT®
TD and ALERT® Companion II are not
approved for sale in the United States. This
product utilizes a natural latex balloon and
should be used with caution in patients with
known sensitivity to latex proteins. ALERT is a
registered trademark of EP MedSystems a wholly
owned subsidiary of EP MedSystems Inc. Pentium is
a registered trademark of Intel.
*This product is not for sale or use in
the U.S.
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