Implanted electrothera-py device musters FDA approval after two years
UTD researchers received FDA approval for their stroke rehabilitation device, bringing eight years of research by over 500 students and faculty to fruition.
In 2013, the UTD Texas Biomedical Device Center set out to create a device that would increase the stroke recovery rate. At the time, PhD students Ben Porter and Navid Khodaparast demonstrated that it was possible to increase the recovery rate from stroke in rats. In 2016, a team led by Seth Hays, Robert Rennaker and Michael Kilgard conducted the first human trial for this innovation and by 2021, phase three clinical trials were published in the medical journal “The Lancet.”The team’s most recent achievement was the FDA approval of the Vivistim paired VNS System, a device that uses vagus nerve stimulation to improve motor recovery for stroke patients.
The device uses a surgically implanted mechanism that sends electrical signals to stimulate the vagus nerve, which can aid in a patient’s recovery of motor function following a stroke.
Furthermore, this device uses 100 times less electrical stimuli than devices the FDA approved over 20 years ago for the same result. Possible side effects consist of mild surgical complications and discomfort surrounding the area of the implant when the vagus nerve is stimulated during rehabilitation sessions.
“The side effects we saw from the clinical trials only occurred when the vagus nerve was being stimulated, but other than that, there are no other major side effects,” Kilgard said.
The Vivistim paired VNS system was completed in 2019 but had been awaiting FDA approval for the last two years. Kilgard said the majority of treatments created for psychiatric and neurological diseases have a high failure rate, so the fact that this device is now FDA-approved was an unexpected outcome.
“We start off working on a project with a 99% chance of failure in mind; [usually] the side effects are either too big, or the effectiveness is too low,“ Kilgard said. “Now that we’ve proven the effectiveness for this rare case, we can go ahead and test other cases as well.”
The Device Center partnered with the company MicroTransponder to put their device out in the biomedical commercial market. UTD licensed the device technology to MicroTransponder in order to make it accessible to the healthcare community.
“Early next year, the company will initially provide these devices to a few local sites but eventually plan to market it around the world,” Kilgard said. “There are certainly some barriers to adoption since it’s a surgical implant, but other than that, it will be widely available.”
Currently, the team is running three new clinical trials, with the first one involving a device that works similarly to the Vivistim paired VNS System but is much smaller. The second trial is for using this device to treat spinal cord injury, and the third trial is for testing the device to potentially aid people with PTSD.
“The possibilities are endless,” Kilgard said. “This device could potentially aid veterans who’ve been to Iraq or Afghanistan or people who have suffered from some sort of trauma.”
The team is currently recruiting people with PTSD or spinal cord injuries and those who are recovering from stroke to participate in clinical trials. For more information about participating in the trials, visit the Texas Biomedical Device Center’s website.
“The real benefit [of the approval] is for the patient population. If 100 years ago you had a stroke, they would tell you to practice motor movements, and that’s even what we do now,” Kilgard said. “After this approval, people will be able to go to their doctor and say they want this neuroscience-designed treatment.”