Inspire Medical Systems Inc has received approval from the US 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,” says Tim Herbert, president and CEO of Inspire, in a release. “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.”
Inspire’s proprietary Inspire therapy is the first and only FDA-approved neurostimulation technology that provides a safe and effective treatment for moderate to severe obstructive sleep apnea.
Last August, the FDA granted Inspire Breakthrough Device Designation for a potential increase in the upper limit of AHI and BMI for patients to be eligible for Inspire upper airway stimulation for obstructive sleep apnea. The FDA’s Breakthrough Therapy program was created to help patients and healthcare providers receive faster access to innovative technologies that hold the potential to provide more effective treatment of irreversibly debilitating diseases or conditions.
The approval follows another expanded indication the FDA granted Inspire in March, which allowed Inspire to offer therapy to pediatric patients with Down syndrome.