FAQ’s

Synapse Biomedical Inc. (SBI) was founded in September 2002 in Oberlin, Ohio. Synapse Biomedical is focused on the commercialization of the NeuRx^® DPS, a life-transforming neurostimulation platform technology, to treat people with respiratory insufficiency. The NeuRx^® DPS was developed over the course of 20 years through a joint effort of physicians and engineers at several institutions, including Case Western Reserve University, University Hospitals Case Medical Center and the Veterans Administration Medical Center.

The NeuRx DPS^® was developed at Case Western Reserve University and the University Hospitals Case Medical Center. Funding was made possible in part by the Department of Veterans Affairs, who contributed more than $1 million.

Synapse’s Co-founder, CEO and President is Anthony Ignagni. The Chief Operating Officer & Managing Director Europe is Moustapha Diop.

CE Mark (CE Registration #518356) in November 2007, for treating patients with diaphragm dysfunction in the European Union. In June 2008 Synapse received FDA approval for the use of its NeuRx DPS^® for patients with spinal cord injury who can no longer breathe on their own.

The NeuRx DPS® provides silent, rhythmic electrical stimulation to your diaphragm, causing it to contract. The NeuRx DPS® is made up of four electrodes implanted in the diaphragm to stimulate the muscle, a fifth electrode under the skin to complete the electrical circuit, a connector holder, a cable and an external battery powered pulse generator.

As a diaphragm pacing system, the NeuRx DPS® provides a more natural form of ventilation by electrically stimulating the muscle and nerves throughout the diaphragm. When stimulated by the NeuRx DPS®, the diaphragm contracts which mimics natural breathing and allows air to fill the lungs rather than forcing air in like a mechanical ventilator.

The state-of-the-art NeuRx DPS® is engineered to provide a means for more natural breathing and help liberate you from mechanical ventilation.

In a survey¹, 96.5% of users reported being happy or very happy with their decision to have the NeuRx DPS® implanted. They also reported using the NeuRx DPS® has:

• Increased their freedom and independence by allowing them to be less dependent on mechanical ventilation,
• Made transferring easier,
• Improved mobility, and
• Made them less noticed in public then when using a mechanical ventilator

¹ Monden KR, Coker J, Charlifue S, Bennett SJ, Draganich C, Coons D, Marino RJ, Berliner J. Long-Term Follow-Up of Individuals with Ventilator Dependent High Tetraplegia Managed with Diaphragmatic Pacing Systems. Arch Phys Med Rehabil. 2021 Mar 22:S0003-9993(21)00238-0. doi: 10.1016/j.apmr.2021.03.005. Epub ahead of print. PMID: 33766556.

There are two batteries in the NeuRx DPS^®. The first is a user replaceable disposable lithium battery with 500 hours of battery life. The NeuRx DPS^® also has a permanent backup rechargeable battery with approximately 8 hours of battery life that recharges every time a new disposable battery is inserted. The NeuRx DPS^® provides a tone every 10 seconds to alert the patient when the disposable battery needs to be replaced.

To insert the NeuRx DPS® electrodes, a surgeon creates four holes smaller than a dime in the abdomen. In one hole, a laparoscope is inserted to see the diaphragm muscle and four electrodes are placed in areas near the phrenic nerves that control the diaphragm contractions. To find the best spot for each of the electrodes, the surgeon tests a number of areas on the underside of the diaphragm. Once the surgeon has found the 4 best locations, the surgeon will then insert the tips of 4 electrode wires in these locations. The surgeon will put the other ends of the 4 electrode wires on the outside of your body. These 4 wires will come out through your skin in the same area. A fifth electrode wire is then placed just beneath the skin in the same area to complete the wiring. After surgery, you will be able to see about 2 inches of each electrode wire outside of your body.

The surgery is accomplished at certified centers by a skilled Board Certified laparoscopic surgeon. Typically they will be trained in general, trauma or thoracic surgery. The surgeries will initially be proctored by a trained surgeon from an existing treatment center who has performed a minimum number of procedures. Additionally, initial support to the surgical team will be provided by a skilled service technician, typically a trained Respiratory Therapist or Registered Nurse.

The device is available at treatment centers that have been trained to perform the procedure and support the rehabilitation process for the reconditioning of a patient’s diaphragm. We will provide education and training for healthcare providers at any hospital interested in becoming a treatment center.

Click here for the latest list of treatment centers in the US.

The level of discomfort depends on the patients’ level of sensation. Patients may feel tired or sore afterwards while their body heals from the surgery. Pain medications, if appropriate, can then be prescribed by your surgeon or physician.

Depending on your condition before and after surgery, you may need to spend the night in the hospital. You should discuss this with your surgeon before your surgery.

While you are recovering from surgery, a healthcare provider will work with you to determine comfortable stimulation settings that will maximize your diaphragm’s performance. The device’s settings can only be adjusted by a trained clinician.

Before you leave the hospital, your care team will teach you and your caregivers how to use the NeuRx® external pulse generator (EPG). You will receive specific conditioning instructions from your care team. Each SCI patient’s success of weaning from the ventilator with the NeuRx DPS® varies. Yours will depend upon your physical condition, your motivation to reduce your reliance on positive pressure ventilation, and the support of your caregivers.

The first patient to be implanted was a 36-year old man from Ohio who was injured July 1998 in a swimming pool accident In March 2000, 18 months after the incident, he underwent laparoscopic surgery, at University Hospitals in Cleveland, to implant the electrodes. After several months of diaphragm conditioning, he was weaned completely off his mechanical ventilator.

The NeuRx^® DPS has been implanted over 125 spinal cord injured individuals in the United States with highlevel spinal cord injury. The longest term patient was implanted March 6, 2000 and has been using the DPS System as his means of respiratory support (24 hours per day) for over ten years.

Christopher Reeve was the third patient to be implanted with the NeuRx DPS^®. After a fluoroscopic examination of diaphragm movement and studies of his phrenic nerve activity, it was determined that his phrenic nerves were intact and he qualified for the procedure, still in clinical trials at the time. On February 28, 2003, he underwent a surgical procedure at University Hospitals Case Medical Center to implant the electrodes. Two days after his operation, he was back to work and gave a talk at Harvard University. On March 9, 2003, he returned to Cleveland to begin the reconditioning process of strengthening the diaphragm through intermittent stimulations. Unfortunately, Christopher Reeve did not achieve complete weaning but had successfully achieved durations of over 12 hours off the ventilator. Christopher Reeve elected to continue using the system throughout his course of treatment until his death.

The cost will vary based on the insurance plan.  You will need to coordinate information regarding pre-approval and reimbursement processes with your healthcare provider and your insurance company. Synapse Biomedical, Inc. has provided treatment centers with insurance reimbursement information to assist you in obtaining coverage.

For spinal cord injury patients, the results have varied from patient-to-patient. It depends on the patient’s motivation to reduce his or her reliance on positive pressure ventilation and the support of the caregivers. In clinical trials, of 49 patients implanted over 6 months:

• 1 out of 2 patients achieved full-time pacing and were able to eliminate their use of positive pressure ventilation.
• 2 out of 3 study participants pace over 12 hours per day and significantly reduced their time on positive pressure ventilation
• 9 out of 10 able to pace for >4 continuous hrs and many continue to work to condition and strengthen their diaphragm.

SCI is damage to the spinal cord that can result in loss of function, such as mobility or feeling.

As of January 2008, the National Spinal Cord Injury Database estimates 227,000 – 300,000 individuals in the United States live with SCI and about 12,000 new cases of SCI occur each year. It is estimated that approximately 500 new cases of mechanical ventilator dependency occur each year that would be eligible for diaphragm pacing.

The leading causes of SCI injuries are vehicle crashes (47%), falls (22%) and violence (~14%). Other causes are trauma, sports injuries or disease, such as polio or spinal bifida.

No. SCI can be divided into three groups depending on the location of the injury. High tetraplegia injuries are cervical spine injuries between vertebra C1-C4. Low tetraplegia injuries are cervical spine injuries between vertebra C5-C8 and paraplegia are typically vertebra injuries of thoracic, lumbar vertebra or sacrum. All of these injuries result in impairment of sensory and motor functions to a varying degree.

The higher the site of the injury, the greater number of nerves affected, which can result in partial or complete paraplegia (legs). Tetra injuries can affect the arms and legs and in some instances cause ventilator dependency. A 20 year old tetraplegic patient with ventilator dependency has a decreased life expectance of more than 14 years compared to a tetraplegic patient not on a ventilator.

The leading causes of death for spinal cord injury patients are pneumonia, pulmonary emboli and septicemia.

No, at this time there is no cure for spinal cord injury. New research and studies are constantly taking place, in efforts to one day find a remedy.

Synapse is currently marketing the NeuRx DPS^® that can allow some SCI patients, depending on the level of injury, to breathe again without a ventilator. Some spinal cord injuries result in damaged phrenic nerves; therefore, these patients cannot benefit from the implant.

For spinal cord injury patients, the results have varied from patient-to-patient. It depends on the patient’s motivation to reduce his or her reliance on positive pressure ventilation and the support of their caregivers. Completed in 2007, our clinical trial of 53 high-level spinal cord injury patients implanted with the NeuRx DPS® revealed:

• 96% (51/53) participants were able to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day
• 58% (31/53) participants were able to breathe without the assistance of a mechanical ventilator for 24 hours daily use

In addition to being approved for sale in the U.S and Europe, the NeuRx DPS® is approved by PMDA in Japan and has been distributed in Canada, Australia, Brazil, Israel and other countries in the Middle East, Scandinavian countries, South Africa, Switzerland, and other countries in South America and North Africa. To date, over 2,000 NeuRx DPS® devices have been implanted world-wide.

Click here for more information on the NeuRx® Diaphragm Pacing System.