Medical technology company Inspire Medical Systems has received approval from the US Food and Drug Administration for an expanded indication that increases the upper limit of the Apnea Hypopnea Index (AHI) to 100 events per hour from 65, and raises the Body Mass Index warning in labeling to 40 from 32. The update will provide a safe and effective treatment option for patients with moderate to severe obstructive sleep apnea who had limited options previously. Inspire's proprietary Inspire therapy is the first and only FDA-approved neurostimulation technology that provides a safe and effective treatment for this patient population. Data from Inspire's ADHERE registry demonstrated that it is a safe and effective treatment for patients with AHI up to 100 events per hour.
Keywords: Inspire Medical Systems, FDA, medical technology, Apnea Hypopnea Index, Body Mass Index
Inspire Medical Systems has announced its receipt of FDA approval for an expanded indication that increases the upper limit of the Apnea Hypopnea Index (AHI) to 100 events per hour from 65, providing a safe and effective treatment option for patients with moderate to severe obstructive sleep apnea who had limited options previously.