The NeuRX RA/4 System is a system designed to help patient’s breathing by stimulation of their diaphragm muscles. The stimulator provides repetitive electrical stimulation to the implanted electrodes to cause the patient’s diaphragm to contract and help the patient to breathe.
More about Diaphragm Pacing Implant
The NeuRX RA/4 System is a system designed to help patient's breathing by stimulation of their diaphragm muscles. The stimulator provides repetitive electrical stimulation to the implanted electrodes to cause the patient's diaphragm to contract and cause the patient to draw breath in a manner similar to natural breathing.
The electrode wires are implanted using laparoscopic surgical techniques in an outpatient procedure. The implanted intramuscular diaphragm electrodes are connected to the NeuRx RA/4 external stimulator through the Patient Cable and the Connector Holder site.
A physician will program the Stimulator so that it produces the right stimulation patterns for the patient. The user simply connects the device to the implanted electrodes and turns it on for use; no other controls are available or necessary for operation.
The stimulator can be placed in a pocket of the patient's clothing, a fanny pack or simply placed on a table or other convenient location.
Clinical trials in ALS
The NeuRx DPSTM is currently under a controlled clinical trial.
Initial study of the device in ALS provided the feasibility of using diaphragmic pacing to slow the decline in a patient's Forced Vital Capacity and delay the onset of respiratory failure. Data from our pilot study revealed the average pre-implant rate of decline was calculated at -2.8% per month and for patients with at least 9 months post-implant follow-up the rate changed positively to -1.0% per month.
Synapse Biomedical Inc. are also investigating to determine if the NeuRx DPSTM may be effective in ventilatory support of patients with ALS either decreasing or eliminating the need for negative or positive pressure mechanical ventilation. For information about the open ALS clinical trial please contact:
* University Hospitals of Cleveland
Mary Jo Elmo, ACNP
Cleveland, OH 44106
Office (216) 844-8594
* Johns Hopkins University
Laura Clawson-Research Coordinator
Baltimore, MD 21287
Office (410) 955-8511
* Stanford University
Shirley Paulose- Research Assistant,
Stanford, CA 94305
Neurology Office (650) 724-3792
* Methodist Neurological Institute
Valrie Bickley-Research Coordinator (ALS)
Houston, Texas 77030
Office (713) 441-5192
* Henry Ford Health System
Helen Foley- Research Coordinator
Detroit, MI. 48202
Office (313) 916-3955
* Mayo Clinic
Karen Overstreet- ALS Research Coordinator
Jacksonville, FL 32224
Office (904) 953-8946
* California Pacific Medical Center (CPMC)
Dallas Forshew- Manager, ALS Research
San Francisco, CA 94115
* Mt. Sinai
NYC, NY (212) 659-5643
About the company
Synapse Biomedical Inc (SBI) was founded in September 2002 to commercialize the Diaphragm Pacing System that has been developed over a twenty-year period at Case Western Reserve University and the University Hospitals of Cleveland. The innovative research performed at these institutions has led to significant advances in the state of the art of electrical stimulation for the treatment of chronic insufficiency.respiratory