Inspire Medical Systems has obtained US Food and Drug Administration (FDA) approval for its Inspire Upper Airway Stimulation therapy, which offers an alternative treatment option for patients with moderate to severe obstructive sleep apnoea who have not found relief with traditional treatments.
According to the company, the fully implanted neurostimulation device is claimed to be the first of its kind for sleep apnoea and will be available in the US in the second half of 2014.
The fully implanted system consists of three components: a small generator, a sensing lead and a stimulation lead.
The single external component, a small handheld Inspire sleep remote, turns the therapy on before bed and off upon waking. When activated, Inspire therapy senses breathing patterns and delivers mild stimulation to key airway muscles, which keeps the airway open during sleep.
Compared with other surgical options, this procedure is less invasive as it does not require removal or altering a patient's facial or airway anatomy.
Inspire Medical Systems president and CEO Tim Herbert said FDA approval of Inspire therapy represents a new era of choice for a subset of patients with moderate to severe obstructive sleep apnoea who are unable to use CPAP.
"All of us at Inspire Medical Systems are committed to improving the health and quality of life for these individuals with OSA, and we are excited to make this innovative and much-needed treatment available to patients and physicians," Herbert said.
Sleep apnoea causes people to sleep poorly and raises the long-term risk of heart attack, stroke, high blood pressure and heart failure.
Yale School of Medicine professor Dr Meir Kryger said this therapy represents a major advance in sleep apnoea treatment for some patients who are unable to use or tolerate CPAP therapy.
"Patients with moderate to severe OSA who are not on effective treatment are at an increased risk for cardiovascular disease, accidents and death," Dr Kryger said. "There is a significant need for safe, effective and well-tolerated new treatments in the sleep medicine field."
The company further noted that results of the STAR trial, published earlier this year in the NEJM, showed that patients implanted with Inspire therapy experienced a 68% reduction in apnoea events, a 70% reduction in oxygen desaturation events and significant improvements in daytime functioning.
Image: The fully implanted device represents new treatment option for patients unable to use CPAP. Photo: courtesy of Inspire Medical Systems.