The FDA recently approved improvements to the surgical procedure for implanting neurostimulation devices to treat obstructive sleep apnea (OSA). The Inspire® Upper Airway Stimulation (IUAS) device is used to treat moderate to severe sleep apnea and patients who are unable to use CPAP. Initially, the implant procedure required three incisions, but the FDA has now approved a two-incision implant procedure, which reduces surgical time and patient pain.
For the past 40 years, surgical treatment has been part of a comprehensive treatment regimen for obstructive sleep apnea (OSA). In 2014, a new surgical treatment emerged when the FDA approved the first neurostimulation device to treat OSA. In addition to moderate to severe apnea, other criteria for IUAS include an apnea-hypopnea index between 15 and 65, a BMI in the 32-35 range, less than 25% central apnea and age 18 and older.
How the device works
The IUAS consists of three parts - the implantable pulse generator (IPG), the stimulating lead and the sensing lead. The initial outpatient surgery required three separate incisions to implant the device. An incision is made in the upper neck to place the stimulation lead around the hypoglossal nerve, and another incision is made in the upper chest to place the IPG. A third incision is made in the transverse chest to place the transducer between 5 and 6 ribs. Once the implanted device is activated, it works by sensing the patient's breathing and producing coordinated stimulation of the tongue. This stimulation causes the tongue to stiffen and protrude slightly, opening the airway during sleep.
More effective surgical methods
Following FDA approval of the dual-incision approach, the IPG and sensor are now placed through the same incision. The sensor is located on the front of the chest, deep within the pectoralis major muscle between the second and third ribs. This new technology is an improvement over the three-cut version. The surgery, which originally took about 100 minutes on average, is now about 20 minutes shorter because there is one less incision and then suturing. Patients also experience a smoother recovery because there are fewer surgical sites that can cause postoperative pain. This is also beneficial for women who wear bras because the third incision is located under the typical bra strap area.
Recovery usually takes about 7-10 days due to some soreness at the surgical site. Patients are advised not to resume any strenuous activities for 3-4 weeks after surgery.
- Product Name: Inspire® Upper Airway Irritation (UAS)
- PMA Applicant: Inspire Medical Systems, Inc.
- Address: 5500 Wayzata Blvd. Suite 1600
- Golden Valley, MN 55416 United States
- Approval date: April 14, 2020
- Approval letter: Approval order
