The Upper Airway Stimulation system from Inspire Medical Systems has been an important and effective treatment option for many patients with obstructive sleep apnea. Like any procedure or technology, there are potential important risks to consider. In the United States, the Food and Drug Administration (FDA) maintains the publicly-available Manufacturer and User Facility Device Experience (MAUDE) database that has required reporting of complications related to the device.

As the first surgeon in the Western US to offer Inspire therapy after FDA approval in 2014, I have many patients who have had the Inspire implant for many years. Especially because this was a new technology, we have been vigilant about possible complications related to the device and have been reassured by Inspire’s response to complications over time. For example, other centers experienced issues with the respiratory sensing lead, including separation of the tip from the remainder of the lead. Inspire was quick to redesign the respiratory sensing lead to resolve this problem, and this is exactly the response you would want from a medical device manufacturer.

We have just published a study of complications related to the respiratory sensing lead, focusing on a different type: delayed migration of the respiratory sensing lead. Two of my patients underwent surgery to implant what was a functioning system for many years, and years later then developed symptoms, such as right chest pain or lung/breathing issues. Ultimately, we detected that the tip of the respiratory sensing lead had moved into the space around the lungs. We addressed this in combination with the thoracic surgery team, performing repositioning of the respiratory sensing lead in one case and removing the entire system in the other.

We wanted to share this experience with others but also reviewed the MAUDE database to evaluate whether this complication was reported by others. It turns out that respiratory sensing lead migration occurred, with migration into the space around the lunds being relatively rare. In our study, we presented a protocol for managing patients with symptoms that might be related to the respiratory sensing lead.

Fortunately, Inspire has developed the Inspire V system that was approved by the FDA in August 2024. This system eliminates the respiratory sensing lead entirely, incorporating the respiratory sensing functionality into the implantable pulse generator. Of course, this eliminates the potential for lead migration. There are other advances with the new system, and I believe the Inspire V is an important and helpful step forward in Inspire therapy. We are actively going through the process to offer the Inspire V system at UCLA and look forward to approval in the near future.