The FDA has recently escalated the recall of Inspire Medical’s nerve-stimulating implant used in the treatment of obstructive sleep apnea. This move by the agency involves assigning a Class I recall designation, which is considered the most serious label, due to a manufacturing defect that could lead to ‘electrical leakage.’ This defect may cause issues such as rapid battery drainage, compromised therapy delivery, or potential shocks, although no patient injuries or fatalities have been reported so far.
The recall initially began on June 17, with Inspire Medical urging healthcare providers and patients to schedule routine check-ups. The company has stated that a non-invasive diagnostic process can detect individuals with the defect, but in some cases, a revision surgery may be required to replace the hardware. The FDA has estimated that up to 32 devices could be impacted by this issue.
The implant, known as the Inspire IV implantable pulse generator, is implanted near the collarbone through a minimally invasive outpatient procedure. It functions by sensing breathing patterns and stimulating the hypoglossal nerves responsible for controlling the tongue muscles, thereby keeping the airway open during sleep.
In a separate development in June 2023, the FDA granted a new approval that expanded the implant’s label, allowing it to be used in a wider range of patients. This approval was also highlighted in the agency’s annual report on innovative medical devices. Originally launched in 2014 as a second-line therapy for moderate to severe obstructive sleep apnea, the system has gained traction over the years.
In its most recent quarterly earnings report in May, Inspire disclosed that approximately 1,250 medical centers across the U.S. now offer its therapy. The company reported $164 million in revenue for the first quarter of the year, marking a 28% increase from the previous year. Operating expenses totaled $154.5 million as Inspire continues to invest in expanding its sales force, direct-to-patient marketing initiatives, and research and development activities. The company anticipates a revenue growth of around 26% for the full year of 2024, with projections ranging from $783 million to $793 million.
As the recall unfolds, Inspire Medical Systems remains committed to addressing the issue and ensuring the safety and well-being of patients using its neurostimulation devices for sleep apnea treatment.
