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CONTRAINDICATIONS
Are there Any Reasons Why You Should Not Use the NeuRx Diaphragm Pacing
System (Contraindications)?
None.
INDICATIONS FOR USE
HUMANITARIAN USE DEVICE
Humanitarian Device. Authorized by Federal law for use in the treatment of chronic
hypoventilation in ALS patients. The effectiveness of this device for this use has not
been demonstrated.
CAUTION:
Federal law (USA) restricts this device to sale, distribution and use by or
on the order of a physician.
The NeuRx Diaphragm Pacing System (DPS)
®
is a device. It is meant for patients
who have both ALS and diagnosed breathing problems. For the NeuRx DPS
®
to
work, your breathing muscle (diaphragm) must be able to respond to stimulation. This
can be shown before surgery by a diaphragm movement test or by a breathing nerve
test. You must be able to exhale at least 45% of the air that a typical healthy person
could (in an “FVC” test). You must also be 21 years of age or older.
The breathing nerves (phrenic nerves) provide a path from the spinal cord to the
diaphragm. It is over this path that your brain sends messages to inhale. Both the
right and left phrenic nerves must be at least partially working for the NeuRx DPS
®
to
work. Your phrenic nerves can be tested by your neurologist.
See BEFORE SURGERY: WHAT TO EXPECT for information about these tests.
INFORMATION ON CONDITION OR DISEASE
Amyotrophic lateral sclerosis (ALS) is a disease that affects nerve cells in the brain
and the spinal cord. Certain nerve cells called motor neurons reach from the brain to
the spinal cord and from the spinal cord to the muscles throughout the body. When
the motor neurons die because of ALS, the ability of the brain to start and control
muscle movement is lost. Patients in the later stages of the disease may become
totally paralyzed.
Often ALS affects the motor neurons which reach to the muscles used in breathing. In
this way, ALS can cause the breathing problems described in the Indications for Use
section above.
For more about ALS see the website of the ALS Association:
www.alsa.org/about-als