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Saint Barnabas Medical Center and Kessler Institute for Rehabilitation Team Up to Provide New FDA Approved Device NeuRx Diaphragm Pacing System (DPS)™ Allows Patients with Spinal Cord Injuries to Breathe Without a Ventilator West Orange and Livingston, New Jersey – Saint Barnabas Medical Center and Kessler Institute for Rehabilitation are collaborating to offer a new technology to Spinal Cord Injury patients. On Monday, March 30, general surgeon Michael L. Bilof, M.D., successfully implanted NeuRx Diaphragm Pacing System (DPS) into two individuals with Spinal Cord Injury who are being treated at Kessler Institute for Rehabilitation. “This new technology is transformational. For individuals with Spinal Cord Injuries who are dependent on a ventilator for their breathing, this device can have a profound effect on their quality of life, potentially eliminating the need for a ventilator and allowing them to breathe on their own again,” states Dr. Bilof. The Saint Barnabas Medical Center and Kessler Institute for Rehabilitation program is one of the largest programs in the New York, New Jersey and Pennsylvania region. Saint Barnabas Medical Center is the only approved hospital in New Jersey to perform this procedure. Dr. Bilof, of West Orange, is the first surgeon in the state and among the first surgeons in the U.S. to implant the NeuRx DPS™ in patients with spinal cord injuries. In June 2008, the U.S. Food and Drug Administration (FDA) approved the device for ventilator-dependent Spinal Cord Injury (SCI) patients who lack voluntary control of their diaphragms. “In the past, patients with ventilator dependent spinal cord injury did not have the freedom to breathe on their own without undergoing a very difficult and complicated surgical procedure. The NeuRx DPS™ offers new hope for these patients,” said Steven Kirshblum, M.D., Medical Director and Director of Spinal Cord Injury Rehabilitation at Kessler Institute for Rehabilitation. “We are excited about working with Saint Barnabas Medical Center on this program and being able to offer this new technology to patients with spinal cord injury at Kessler. Following the procedure, the two patients returned to Kessler’s West Orange hospital to continue their rehabilitation and begin the weaning protocol. The timeframe for decreasing the use of the ventilator is contingent upon the individual’s personal progress, strength and conditioning, explained Dr. Kirshblum. The device, implanted through minimally invasive laparoscopic surgery, provides electrical stimulation to muscle and nerves in the diaphragm. When the muscle is stimulated by the NeuRx DPS™, 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. “We are thrilled that Saint Barnabas Medical Center will now be implanting the NeuRx DPS™,” said Anthony R. Ignagni, Synapse Biomedical President and Chief Executive Officer. “The collaboration between the Saint Barnabas Medical Center and Kessler Institute for Rehabilitation makes them perfect partners for Synapse Biomedical to offer this breakthrough technology to spinal cord injury patients with ventilator dependency.” Candidates for Treatment Candidates for the NeuRx DPS™ are patients with:
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) SCI injuries that require tracheostomy and mechanical ventilation. Approximately 500 new cases occur each year. Technical description In the clinical trial, NeuRx DPS™ provided 100 percent of SCI patients who had been dependent on mechanical ventilation and with intact phrenic nerves an alternative that allowed them to breathe normally and live more active lives. In the study, 50 percent were able to be completely weaned from the ventilator. Patients may be able to transfer from ventilator units in hospitals or care centers to home or assisted living facilities. Speech patterns, often more difficult and strained in ventilator-dependent patients, may return to normal. The senses of taste and smell, severely diminished in ventilator-dependent patients, may also be recovered. 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 also greatly decreases the patient’s risk of a serious complication: Ventilator Acquired Pneumonia (VAP). Background The NeuRx DPS™ was developed over the course of 20 years through a joint effort of physicians and engineers at several institutions, including University Hospitals Case Medical Center Cleveland, Case Western Reserve University and the Veterans Administration (VA) Medical Center. Funding assistance was provided by the Food and Drug Administration, U.S. Surgical Corporation (a Division of Covidian), University Hospitals Case Medical Center, the VA, and the National Center for Research Resources of the National Institutes of Health. Synapse Biomedical, headquartered in Oberlin, OH, was founded in 2002 to bring its NeuRx™ platform of diaphragmatic pacing technologies to market. These technology platforms resolve a number of respiratory clinical needs and create a neurostimulation market segment for these treatments. Surgical procedure Using a form of minimally invasive laparoscopic surgery, a surgeon creates four dime-size holes in the abdominal region and inserts a laparoscope so that 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 outpatient basis, with a short rehabilitation period. The patient then 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. Saint Barnabas Medical Center Since 1865, Saint Barnabas Medical Center (SBMC), located at 94 Old Short Hills Road in Livingston, is New Jersey’s oldest nonprofit, nonsectarian acute-care hospital. The 597-bed institution is one of the largest heath care providers in the state, treating more than 35,000 inpatients and over 75,000 Emergency Department patients each year. The Medical Center and the Saint Barnabas Ambulatory Care Center provide treatment and services for more than 300,000 outpatient visits annually. Kessler Institute for Rehabilitation Kessler Institute for Rehabilitation, the nation’s largest single rehabilitation hospital, provides comprehensive care and treatment to individuals with spinal cord injury, brain injury, stroke, amputation, neurological diseases and orthopedic conditions. Kessler is one of only six federally-designated Model Systems in the nation for the treatment and research of both spinal cord injury and brain injury. Ranked as one of the top rehabilitation hospitals in the country by U.S. News & World Report, Kessler has three hospital campuses located in West Orange, Saddle Brook and Chester, N.J., and more than 75 outpatient centers throughout the state. For more information, visit www.kessler-rehab.com. Date: March 31, 2009 Saint Barnabas Contact:
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