FDA allows Oberlin lab's 'Superman' device to be used during pandemic (VIDEO)

OBERLIN — Paralyzed by a fall from horseback, "Superman" star Christopher Reeve was among the first patients back in 2003 to test a device designed to help patients move off respiratory ventilators. That early model has grown into a more advanced one, built at Oberlin's industrial park on Artino Street, and today it's helping people diagnosed with COVID-19. Synapse Biomedical received emergency authorization from the U.S. Food and Drug Administration this week to provide its TransAeris diaphragm pacing stimulator to hospitals during the pandemic. The electronic device uses small electrodes implanted through surgery to stimulate the muscle that inflates the lungs. The Oberlin-based company is ramping up production at three laboratory "clean rooms," said President and CEO Tony Ignagni. The technology will significantly cut the time coronavirus patients are hooked up to ventilators, according to Dr. Raymond Onders, a pioneer in diaphragm pacing at University Hospitals and Case Western Reserve University. The hospital system contends the technology could reduce ventilator burden in COVID-19 patients by 26 percent. "The ability to decrease the need for mechanical ventilation will allow more ventilator units for other patients at need," Onders said. The technology has proven helpful in intensive care units, especially for cardiac patients, according to UH. "In spinal cord injured patients, we have decreased time on ventilator from 30 to 10 days," Onders said. "Patients with pneumonias have a significantly decreased amount of ventilator days when (diaphragmatic pacing) is used." Ignagni said TransAeris has been approved for Europe, and was on pace for FDA approval in the United States within two years. That wait may now be as small as a year, thanks in part to the data that will be collected during the coronavirus pandemic, he said. The handheld device is akin to a pacemaker, but instead of stimulating the heart, it helps the diaphragm, Ignagni said. One of the biggest challenges during development has been making the implanted electrodes durable, he said. At 12 to 20 breaths per minute, the average human will breathe in and out 23,000 times per day and 8.4 million times per year. "If you take any kind of wire and flex it that many times, it's going to break. We've had thousands of these in people, and we've never had a wire break," Ignagni said. Now his concern is meeting demand. Production is scaling up to 10 times more devices than Synapse Biomedical has built in the past, he said, with all fabrication in town. Ignagni worries that won't be enough. About half of his 30 employees are working from home, and the others are involved in production. And the Oberlin lab is taking steps to prevent employee exposure to the coronavirus that could further delay TransAeris production. COVID-19 patients aren't the only beneficiaries. Anyone in an intensive care unit could use the device for up to 30 days with a doctor's recommendation, helping to free up ventilators, Ignagni said. Synapse Biomedical is obligated to tell those patients that TransAeris hasn't undergone the same type of review as an officially approved medical device. Its use also carries some risks, including potential infection, lung injury, pain, interference with heart rhythm and, rarely, death during the implantation procedure. The company also acknowledges doctors won't be as familiar with the new technology as they are with traditional ventilator-weaning methods. The same patient fact sheet balances the risks against the dangers of being on a ventilator for a prolonged time: pneumonia, lung injury, damaging the airway and death. Contact Jason Hawk at (440) 329-7122 or news@lcnewspapers.com.