The update includes an increase on the upper limit of the Apnea Hypopnea Index (AHI) to 100 events per hour from 65, and raises the Body Mass Index (BMI) warning in the labeling to 40 from 32
Inspire is a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea. (Credit: Gregory Pappas on Unsplash)
Inspire Medical Systems, a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea (OSA), announced today that it has received approval from the Food and Drug Administration (FDA) on an expanded indication. The update includes an increase on the upper limit of the Apnea Hypopnea Index (AHI) to 100 events per hour from 65, and raises the Body Mass Index (BMI) warning in the labeling to 40 from 32.
“We are excited that the FDA has approved Inspire’s application to expand our indication to include patients with AHI up to 100 events per hour,” said Tim Herbert, President and Chief Executive Officer of Inspire. “These patients experience severe OSA and have historically had limited treatment options available. Data from our ADHERE registry demonstrated that Inspire is a safe and effective treatment for this patient population and we are grateful to our surgeon and sleep physician partners who participated in this registry. Furthermore, we are very pleased that the FDA raised the BMI warning in the labeling to 40 from 32,” concluded Mr. Herbert.
Source: Company Press Release