ALS Statement of Intended Use, Warnings, Precautions, Side Effects, and Contradictions

NeuRx RA/4 Diaphragm Pacing System®

Product technical manual must be reviewed prior to use for detailed disclosure.

Intended Use

The NeuRx Diaphragm Pacing System (DPS)® is a percutaneous, intramuscular, diaphragm motor point stimulating device intended for use in amyotrophic lateral sclerosis (ALS) patients with a stimulatable diaphragm (both right and left portions) as demonstrated by voluntary contraction or phrenic nerve conduction studies, and who are experiencing chronic hypoventilation (CH) , but not progressed to an FVC less than 45% predicted. For use only in patients 21 years of age or older.

Contradictions

None known.

Warnings

If you use the device full time, then you must always have a back-up means of breathing help (ventilation) available. Follow your healthcare provider’s directions in the use of the NeuRx DPS®. Do NOT use the NeuRx DPS® if you are pregnant. Do NOT have any food or liquid in your mouth when you start conditioning. NeuRx DPS® could interfere with some medical equipment. Some medical equipment could interfere with the NeuRx DPS®. Call your healthcare provider who is helping you with your NeuRx DPS® before having any of the following: implanted cardiac pacemaker or defibrillator, surgery, magnetic resonance imaging (MRI) test, diathermy treatment, external electrical stimulation such as transcutaneous electrical nerve stimulation (TENS), or shortwave or microwave therapy. Do NOT use this device if the skin around the electrode wires gets swollen, infected, or inflamed. Do NOT use the NeuRx® EPG in an oxygen enriched environment or near a flammable anesthetic mixture with air, oxygen or nitrous oxide.

Precautions

If you think the device is not providing enough stimulation, then call your healthcare provider. Some patients may feel skin irritation or sensitivity because of the NeuRx DPS™. Call your healthcare provider if this occurs. Avoid touching the patient cable or electrode wires to other metal objects. To avoid damage to the device, keep this device out of the reach of children. Do NOT attempt to open the NeuRx™ External Pulse Generator (EPG). Do NOT drop the NeuRx™ EPG. Do NOT allow the NeuRx®EPG to get wet. Do NOT get wet while using the NeuRx® EPG. This includes bathing, showering, swimming, or any other activity in which you could get wet. Do NOT have the EPG connected during any type of electrical diagnostic test such as an electromyogram (EMG) or electrocardiogram (ECG). Electromagnetic Interference: When using your NeuRx® EPG around electrical equipment, check the NeuRx® EPG screen to make sure the EPG is working. Do NOT use cables or accessories with your NeuRx® EPG other than those specified.

Adverse Events

In 86 clinical trial patients, 3 patients (3.5%) experienced a serious adverse effect which was related or possibly related to the surgical implantation procedure: i.e., capnothorax (in 2 patients or 2.3%) requiring catheter placement or an extended hospital stay; and respiratory failure following complications from surgery (in 1 patient or 1.2%) after the migration outside of the stomach of a percutaneous endoscopic gastrostomy (PEG) tube placed following electrode implantation. There were no reports of any serious adverse effects related to the patients’ use of the device following discharge. The most commonly reported non-serious adverse effects were capnothorax, mild to moderate discomfort from stimulation, infection where the electrode wire passes through the skin (exit site), and malfunction of device components resulting in a loss or diminution of conditioning therapy until resolution.

Humanitarian Use 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 by or on the order of a physician.

Please refer to the NeuRx Diaphragm Pacing System® Product Patient manual prior to use.

For More Information, Contact:

Synapse Biomedical, Inc.
300 Artino Street
Oberlin, Ohio 44074
Tel: 888.767.3770
Fax: 440.774.2572
info@synapsebiomedical.com

Synapse Biomedical Europe S.A.R.L
156 Place des Aubépines
95680 Montlignon, France
Tel: +33 (0)9.60.12.44.98
Fax: +33 (0)1.74.18.08.19
mdiop@synapsebiomedical.com