MedAutonomic said today it has successfully implanted a brain neuromodulation device, the Phoenix, into the stomach wall of a human through an innovative digestive endoscopic procedure.
Powered without a battery, the Phoenix sends signals to the limbic system to reset an imbalance in the autonomic nervous system to treat metabolic syndrome and functional diseases such as type-2 diabetes, hypertension, and gastroesophageal reflux disease, according to a company statement.
The company developed a piezoelectric energy harvesting system (PEHS) to power the Phoenix. The PEHS is incorporated in the “tail” of the device and captures the biologic energy from the natural peristaltic movement and vibrations of the stomach, according to the company’s website. The correct precise signal to the brain is calibrated by the CPU housed in the body of the device. Signals are sent to the brain via gold electrodes.
The first human implant represents an important milestone for the company, said MedAutonomic president and lead researcher, Dr. Valerio Cigaina.
“The outpatient procedure using a gastric endoscope has been perfected, and we are able to implant our device without surgery in less than ten minutes,” Cigaina said. “We are pleased to be the first to insert a diagnostic and/or therapeutic device in the gastric wall in a minimally invasive way, with the device perfectly tolerated over the long term. The Phoenix is sending a signal to the brain, which is confirmed by heart rate variability.”
Based in Concord, Calif. and Venice, Italy, the company will next conduct trials to attain the CE Mark.