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Thomas Jefferson University Hospital (TJUH) in Philadelphia is the first hospital in Pennsylvania to offer a FDA-approved device that helps individuals with certain types of spinal cord injuries breathe on their own again.  Michael Weinstein, M.D., assistant professor in the Department of Surgery at Jefferson, is among the first surgeons in the United States to implant the NeuRx DPS™ in patients with spinal cord injuries who lack voluntary control of their diaphragms.  The device provides electrical stimulation to muscle and nerves in the diaphragm.  When the muscle is stimulated, the diaphragm contracts and creates a vacuum-like effect in the chest cavity that allows air to fill the upper and lower parts of the lungs.  When this contraction eases, the air is expelled from the lungs – essentially the same as regular breathing. 

“In the past, spinal cord injury patients were tethered to a respirator and did not have the freedom to taste foods, smell or breathe on their own,” said Dr. Weinstein.  “We are excited about being able to offer the benefits of this device at Jefferson and to offer new hope to patients living with spinal cord injury.”

Using a form of minimally invasive laparoscopic surgery, four dime-size holes are created in the abdominal region and a laparoscope is inserted so the diaphragm muscle can be seen.  The surgeon then places small electrodes in the diaphragm.  The electrodes are attached through wires under the skin to a small external battery-powered pulse generator that stimulates contraction of the diaphragm muscle, which allows the patient to breathe.

The surgery is done on an inpatient basis, with a short rehabilitation period often beginning the very next day.  During this time the patient has the NeuRx DPS™ programmed to allow him or her to effectively yet comfortably breathe.  Because of the patient’s injury, the diaphragm is weak and at first the patient can only breathe with NeuRx DPS™ for a short period of time.  The patient has to condition and strengthen the diaphragm, which allows increasing amount of time off of the ventilator on an almost daily basis.  Many patients are able to free themselves completely from the ventilator.

“Patients may be able to transfer from ventilator wards to home or assisted living, and even travel,” said Ralph Marino, M.D., director, Regional Spinal Cord Injury Center of the Delaware Valley at TJUH, and associate professor, Department of Rehabilitation Medicine at Jefferson Medical College.  “Speech patterns, often laborious and strained in ventilator-dependent patients, become more natural.  Because air is now able to flow in through the nose the senses of taste and smell, severely diminished in ventilator-dependent patients, return.”

Controlled through a four-channel battery-powered external pulse generator, the NeuRx DPS™ eliminates the need for a source of electricity and the concern for power outages.  Patients and caregivers are easily trained in the use of the NeuRx DPS™, reducing the need for external medical supervision.  Elimination and reduction of the use of a mechanical ventilator can also greatly reduces the patient’s risk of a serious complication: Ventilator Acquire Pneumonia (VAP).

Candidates for the NeuRx DPS™ are patients with:

• High level spinal cord injury resulting in dependence on ventilation
• Bilateral intact phrenic nerves below the level of the spinal cord injury
• General good health otherwise

The majority of eligible patients have suffered injury through motor vehicle accidents and sports injuries.  An estimated 3,700 individuals in the U.S. live with high (C1-C3) spinal cord injuries that require tracheostomy and mechanical ventilation.  Approximately 500 new cases occur each year.

About Synapse Biomedical
Founded in 2002, Synapse Biomedical’s www.synapsebiomedical.com mission is to commercialize its life-transforming neurostimulation platform in order to treat people with respiratory insufficiency.  Synapse is based in Oberlin, Ohio, approximately 30 miles west of Cleveland.