US authorities have approved a first-of-its-kind implant to treat patients with moderate to severe Obstructive Sleep Apnea (OSA), a chronic disorder that affects about 18 million Americans.
The US Food and Drug Administration (FDA) has approved the Inspire Upper Airway Stimulation (UAS) therapy which is a fully implanted system consisting of three components: a small generator, a sensing lead and a stimulation lead.
The single external component is a small handheld sleep remote used to turn the therapy on before bed and off upon waking.
When activated, the therapy senses breathing patterns and delivers mild stimulation to key airway muscles, which keeps the airway open during sleep.
In contrast to other surgical options to treat sleep apnea, Inspire therapy does not require removal or permanent alteration of facial or airway anatomy. As such, the procedure is less invasive and should result in a shorter recovery time.
"The FDA approval of Inspire therapy represents a new era of choice for a subset of patients with moderate to severe Obstructive Sleep Apnea who are unable to use CPAP," said Tim Herbert, president and CEO, Inspire Medical Systems, a company based in Minneapolis.
Continuous Positive Airway Pressure (CPAP) is the current standard of care for OSA management. It is often successful but recent studies have shown that roughly half of all patients that start CPAP do not continue to consistently use it.
Patients implanted with Inspire therapy who participated in a pivotal clinical trial experienced a 68 per cent reduction in apnea events, a 70 per cent reduction in oxygen desaturation events, and significant improvements in daytime functioning as measured by two validated questionnaires.
These results were published in the New England Journal of Medicine.
Inspire therapy will be commercially available to patients in the US in the second half of 2014.
