Inspire Medical Systems: Implant for the treatment of obstructive sleep apnea

Main article: OSA - obstructive sleep apnea syndrome

2024: Popular apnea implants Inspire Medical Systems shock and lead to new surgeries

In mid-July 2024, regulators withdrew Inspire Medical Systems' popular implantable pulse generators for sleep apnea from the market as they shock and lead to new operations.

A Class I recall, the most serious level, involves removing devices from use or sale. The recall affected 32 devices of the 3028 IPG model. No injuries or deaths related to this recall have been reported, the company said.

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Фото: Sleep Review

Implantable generators were developed for the treatment of sleep apnea with the ability to maintain the therapy settings set by the attending physician. The implant provides mild electrical stimulation to the sublingual nerve, which controls the muscles of the tongue, which maintains airway patency during sleep. Inspire implants receive the program from the outside, allowing doctors to set and adjust therapy parameters.

Inspire Medical had to recall Model 3028 due to a manufacturing defect, according to a regulatory notice. This defect can cause system malfunctions after implantation, resulting in the generation of unnecessary electrical pulses. As a result, patients may need revision surgery to replace the implant and resume therapy.

Although the company has not reported any side effects, the use of a defective product can lead to adverse health effects. These include stimulation below normal therapeutic levels and/or early battery discharge leading to early discontinuation of therapy. Patients also note inappropriate or improper stimulation and soreness. In addition, incorrect generation of electrical pulses can be life-threatening.^[1]

2023: Obtaining Use Authorization from the FDA

The company Inspire Medical Systems has received American from the regulator () industries health care FDA extended permission to use its eponymous medical treatment device, which obstructive sleep apnea (OSA) should increase the number of people who can apply such treatment. This became known on June 23, 2023.

Inspire Medical Systems Gets Approval to Sell Obstructive Sleep Apnea Treatment Device

OSA is a common condition that causes breathing to break during sleep, which can have serious health consequences, including an increased risk of high blood pressure, heart attack, stroke and diabetes.

The Inspire nerve-stimulating implant provides easy stimulation of the nerve in the patient's jaw during sleep, helping to keep part of the upper airway open by moving the tongue forward, and is switched on by the patient using a remote control.

Like a pacemaker, the device implants in the chest and is seen as an alternative to more common and bulky SIPAP devices that require nighttime mask wearing.

The device was first approved by the FDA in 2014 as a second-line therapy for moderate to severe OSA, which cannot be managed with weight loss, positional therapy, or SIPAP devices. Previous FDA approval included some limitations, namely, patients should not have complete airway blockage, cannot undergo a tonsillectomy or other corrective soft tissue surgery, cannot tolerate SIPAP therapy, and are not obese. It was also approved for use in patients with an average of no more than 65 episodes of apnea and hypopnea per hour of sleep - an indicator known as the apnea-hypopnea index.

Now the maximum indicator of this index has been increased to 100 episodes, which classifies patients as the upper part of the severe category. At the same time, the wording of the warning inscription on the device has been changed, which previously stated that the device was not tested in people with a body mass index of more than 32, now it is upgraded to a body mass index of 40.

While Inspire remains the only FDA-approved implantable OSA treatment device, it has several competitors on the market, such as Signifier Medical Technologies' eXciteOSA, which also uses electrical muscle stimulation to treat the disease.

However, in this case, a removable device is used while the patient is awake to improve the function of the muscles of the tongue, helping to prevent it from falling back and interfering with the respiratory tract during sleep. The device was approved by the FDA in 2021.

Inspire continues to work on improvements to the implant, including the addition of software that will record a picture of sleep apnea and transmit data via Bluetooth for doctor viewing^[2].

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