Sleep Apnea Implant Receives FDA Approval

Less than four hours after the first version obtained permission, the FDA approved an improved version of Respicardia’s sleep apnea “Remede” system, allowing Zoll Medical to begin rolling out the Remede EL-X system at medical organizations across the United States.The investment in the acquisition of neurostimulation device maker Respicardia is already paying off just a few months later.

The system’s main component is a tiny neurostimulator, which is inserted in the upper region of the chest. The electrodes stimulate the phrenic nerve in the chest, which helps control breathing patterns by controlling brain messages to the diaphragm.The minimally invasive procedure attracts physicians and patients seeking to undergo treatment for sleep apnea.

Central sleep apnea is caused by errors in nerve signals from the brain to the diaphragm. This causes irregular breathing during sleep as opposed to obstructive sleep apnea, in which a physical blockage occurs in the upper respiratory tract. The electrodes in the Remede system monitor breathing patterns throughout the night, sending signals to the nerve as needed to stabilize breaths for patients suffering with central sleep apnea.

During the three year study, apnea symptoms of the patients decreased significantly by more than 90%. Also, patients reported major improvements in sleep, with approximately 60% fewer awakenings and a 14% increase in deeper sleep, according to a clinical trial of the Remede system. Additionally, significant improvements in the patients quality of life was reported by more than 80% of those that took part.

Advances in the newly certified EL-X system includes a 25% reduction in size and a 40% longer lasting battery. Unlike the original device, the new system has only one lead electrode that stimulates the phrenic nerve and monitors breathing at the same time.

The new system also integrates a new software platform that collects all of the data including measurements of breathing patterns and activity of neurostimulation. All data is then compiled into a diagnostic report over the course of the night. According to Todd Goblish, vice president of R&D at Zoll Respicardia, care teams may utilize the reports to track how each patient is responding to the system and alter their treatment regimens on a regular basis.

Zoll CEO, Jon Rennert, said that the company planned to integrate its own respiratory and cardiac health products with the Remede system to monopolize the market for central sleep apnea. All of Respicardia’s employees joined Zoll’s staff in Massachusetts as part of the buyout, with Respicardia’s Minnesota headquarters remaining. The deal’s financial specifics were not disclosed, however, it expanded on Zoll’s long-term commitment to Respicardia, which included managing the company’s $58.5 million financing in 2017.

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