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Consumer Information on: NeuRx DPS?, Diaphragm Pacing System - H100006

Wed, 11/23/2011 - 7:45pm
U.S. Food & Drug Administration

Product Name: NeuRx Diaphragm Pacing System™

Manufacturer: Synapse Biomedical, Inc.

Address: 300 Artino Street, Cleveland, Ohio 44074

Approval Date: September 28, 2011

Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf10/h100006a.pdf

What is it? The NeuRX Diaphragm Pacing System™ is an intramuscular, percutaneous, and motor point diaphragm stimulation system. It is implanted using standard laparoscopic surgical techniques in an implanted device that is placed via laparoscopic surgical techniques in an outpatient procedure. The implanted intramuscular diaphragm electrodes are connected to a four channel external pulse generator at a percutaneous exit site. The pulse generator provides a capacitively coupled, charged balanced, biphasic stimulation to each electrode with a common indifferent electrode that is placed subcutaneously. The pulse generator controls the charge delivered through clinician programmed parameters of pulse amplitude, pulse duration, pulse frequency, pulse ramp, inspiration time, and respiratory rate. The clinician uses a clinical station to evaluate electrode response to stimulation and program the external pulse generator with the patient specific parameters. The user simply connects the device and turns it on for use; no other controls are available or necessary for operation.

How does it work? The NeuRX Diaphragm Pacing System™ is implanted using standard laparoscopic surgical techniques in an outpatient procedure. The implanted intramuscular diaphragm electrodes are connected to a four channel external pulse generator at a percutaneous exit site. The pulse generator provides a capacitively coupled, charge balanced, biphasic stimulation to each electrode with a common indifferent electrode that is placed subcutaneously. The pulse generator controls the charge delivered through clinician programmed parameters of pulse amplitude, pulse duration, pulse frequency, pulse ramp, inspiration time, and respiratory rate. The clinician uses a clinical station to evaluate electrode response to stimulation and program the external pulse generator with the patient specific parameters. The user simply connects the device and turns it on for use; no other controls are available or necessary for operation.

When is it used?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. The device is indicated for use in patients 21 years of age or older.

What will it accomplish? It may provide diaphragm strengthening, a symptomatic treatment for respiratory instability from upper motor neuron loss as a result of the general progression of ALS.

When should it not be used? The device should only be used to provide diaphragm strengthening, a symptomatic treatment for respiratory instability from upper motor neuron loss as a result of the general progression of ALS.

Additional information: SSPB and Labeling will be available online.

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