The FDA granted a breakthrough designation to a neurostimulation device designed to strengthen the diaphragm and help wean people who are having difficulty breathing on their own off of mechanical ventilation.
Stimdia Medical hopes its pdSTIM system can help clinicians address high-risk patients suffering from COVID-19 and other conditions as well as avoid some of the complications that can come with the intensive rescue therapy.
This includes ventilator-induced diaphragmatic dysfunction, or VIDD, where the muscle’s fibers can atrophy or sustain injuries after prolonged mechanical breathing support. This condition has been linked to longer recovery times and higher mortality rates.
“Over 40% of ICU admissions in the U.S. require mechanical ventilation with an average length of stay of 14 days for ventilated patients and an estimated annual cost of over $27 billion,” said Stimdia General Manager Tim Miller. “We believe the pdSTIM System will help to reduce both length of stay and costs by enabling more rapid weaning of patients from mechanical ventilators.”
The minimally invasive system aims to electrically stimulate the nerves in both sides of the patient’s neck to help exercise the diaphragm in sync with mechanical ventilation.
A previous clinical study demonstrated that the system was able to safely connect with the neck’s phrenic nerves and synchronize with breathing, and it showed patients’ diaphragms became 7.8% thicker after 24 hours of therapy and 15% thicker after 48 hours. The system has not yet been reviewed or approved by the FDA.