The FDA has just approved a device developed by Synapse Biomedical (Oberlin, Ohio) to help paralyzed patients breathe without a traditional ventilator the same one implanted in Christopher Reeve in 2003 which allowed him to be ventilator-free for 20 hours a day.
"If you think about where cardiac pacing was in the early 1950s and 1960s, that is where we are with pulmonary rhythm management now," Anthony Ignagni, Synapse president/CEO, told Medical Device Daily.
The NeuRx DPS for ventilator-dependent spinal cord injury (SCI) patients who lack voluntary control of their diaphragms is implanted through minimally invasive laparoscopic surgery. It provides electrical stimulation to muscles and nerves that run through the diaphragm.
When stimulated by the NeuRx DPS, the diaphragm contracts, mimicking natural breathing, and allows air to fill the upper and lower parts of the lungs rather than forcing air in with a mechanical ventilator.
"Our first patient was implanted in March 2000 and has been using it ever since 24 hours a day, seven days a week," Ignagni said. "Over half of our patients can use it full time. We set a minimum bar to say it's successful at four hours of continuous use. We've implanted patients who are 27 years post-injury."
Ignagni said 140 patients have been implanted to date via clinical trials.
The FDA approval is based on studies of 50 patients implanted with the device in clinical trials at hospitals in the U.S. and Canada. All of the implanting surgeons were trained under the direction of Raymond Onders, MD, director of minimally invasive surgery at University Hospitals (Cleveland) and a founder, board member and shareholder of Synapse.
In the clinical trial, NeuRx DPS allowed 98% of SCI patients who had been dependent on mechanical ventilation via a tracheostomy with an alternative that allowed them to breathe normally and live more active lives. To date, more than half are able to completely eliminate their need for mechanical ventilation.
The NeuRx DPS is controlled via a four-channel, battery-powered external pulse generator, which negates the need for a source of electricity and the concern for power outages.
Elimination and reduction of the use of a mechanical ventilator also greatly reduces the patient's risk of complications such as ventilator acquired pneumonia, which occurs in 50% of SCI patients.
The best patient candidates are those with high-level spinal cord injury with stimulatable diaphragms, but who lack control of their diaphragm, resulting in the need for mechanical ventilation. The majority of these eligible patients have been hurt through motor vehicle accidents and sports injuries.
During outpatient surgery, four dime-size holes are created in the abdominal region. The surgeon then inserts a laparoscope so that the diaphragm muscle can be seen. Small electrodes are placed within the diaphragm and attached through wires under the skin to a small external battery-powered pulse generator that stimulates contraction of the diaphragm muscle, allowing the patient to breathe.
Patients need a short rehabilitation period so that their weakened diaphragms can be strengthened, gradually allowing increasing amounts of time off the ventilator. Over time, many are able to free themselves completely from the ventilator.
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, Case Western Reserve University and the Veterans Affairs Medical Center.
"Fortunately, spinal cord injury comprises a small market: 500 new injuries per year in the U.S.," Ignagni said. "What we intended was to use this as an initial application. Now we've moved into Lou Gehrig's disease, which has five times as many patients. We're also looking at other applications in intensive care."
With a price tag of $31,000 (not including surgical implantation costs), the NeuRx DPS is a cost-efficient therapy for patients who need help breathing compared to home mechanical ventilation, which runs up to $180,000 per year, Ignagni said.
The company was able to recoup costs during its testing period with a Category B1 classification and Medicare provided blanket coverage, "so we expect to see good results as we're seeking Medicare reimbursement."
Synapse is manufacturing the NeuRx DPS in-house with no partners, yet.
"As we're moving through these smaller markets, SCI and amyotrophic lateral sclerosis, we haven't see a lot of interest from the larger players," Ignagni said. "But as we move into intensive care and other, larger markets, the interest will come."
Synapse is currently in the midst of a private fund-raising effort which started in May.
The NeuRx DPS received the CE mark in November 2007 and is approved for treating patients with diaphragm dysfunction in the European Union.