Inspire Medical Systems Brand Guidelines: A 2007 Medtronic Spin-Out & a Sleep Apnea Implant

Technology and patents carried out of Medtronic in 2007.

Inspire Medical Systems is a Minnesota medical-device company built around one condition: obstructive sleep apnea. The company says it was formed in 2007, when the Inspire technology and “a significant intellectual property portfolio” were spun out of Medtronic, the Minneapolis-born device maker. Renaissance Capital, reporting on the company’s planned share offering in April 2018, also gives 2007 as the founding year.

Its first chairman was Dr. Glen D. Nelson, who held the role from 2007 to 2016, according to the company’s own history. The company quotes his motto, “if we put the patient first, we will never lose our way,” and says that spirit led to its investment in a patient-experience reporting system.

For much of its early life the company was based in Maple Grove, north-west of Minneapolis: that is the applicant’s address on the FDA’s 2014 approval record and the headquarters in Renaissance Capital’s 2018 profile. Its website now gives a head office in Golden Valley, also in the Minneapolis suburbs.

The therapy belongs to a field called hypoglossal nerve stimulation. Wikipedia’s article on the treatment describes the arrangement: a stimulation lead placed on branches of the hypoglossal nerve, which controls the tongue; a sensing lead in the chest that follows the breathing cycle; and an implanted pulse generator that links the two and is switched on for sleep. The company says the device is placed surgically by an ear, nose and throat surgeon, tailored to each patient by a sleep-medicine professional, and controlled by the patient with a small remote.

Approval in 2014, then a long run of supplements.

The regulatory record is public. The FDA’s premarket-approval database lists application P130008, the Inspire II Upper Airway Stimulator, received on 1 May 2013 and approved on 30 April 2014. The approval order describes the Inspire Upper Airway Stimulation system — an implantable pulse generator, a stimulation lead, a sensing lead, a physician programmer and a patient programmer — for a defined subset of adults with moderate to severe obstructive sleep apnea who could not use or tolerate positive airway pressure machines. The order limits the original approval to patients aged 22 and older, the application was reviewed under the FDA’s anesthesiology advisory committee, and the record links it to a registered clinical trial, NCT01161420.

The same file has since grown to more than a hundred supplements. A panel-track supplement approved in April 2020 lowered the indication’s starting point on the apnea–hypopnea index to 15. Among them, the FDA’s records show approval in March 2023 for use in a subset of adolescents aged 13 to 18 with Down syndrome and severe sleep apnea; a widening in June 2023 that raised the upper limit of the apnea–hypopnea index in the indication from 65 to 100 and the body-mass-index warning from 32 to 40; a Model 2580 Sleep Remote replacing the earlier remote in December 2021; updated SleepSync programming software in June 2023; and, on 1 August 2024, a new implant, the Inspire V Model 3150 pulse generator, described as the new version of the Model 3028.

Some of the smaller entries read like a design log. In April 2022 the FDA approved silicone stimulation and sensing leads in 25 cm and 45 cm lengths; in July 2022 it approved additional MRI scanning conditions; and in September 2022 it approved a change that made the main button of the Model 2580 patient remote slightly smaller. The June 2023 approval covers an updated SleepSync programmer whose software application can be installed on customer-owned devices and paired with the Inspire programmer cable.

The supplements also show something of how the system is made. Approvals name outside sterilisation contractors — a Cirtec Medical site in Enfield, Connecticut, from 2020, and Steris — and an October 2026 notice expands an existing final-device manufacturer’s site to produce the Inspire V generator. The FDA’s recall database lists labelling actions: incorrect use-by dates on labels in 2018 and in 2026, and mismatched serial-number labels on boxed leads in July 2024.

Design and documentation.

Neuromodulation companies sell devices that most people will never see. Spinal cord stimulators, sacral nerve stimulators, hypoglossal nerve implants and brain-computer interfaces sit under the skin or inside the skull, so the companies that make them have to show something else: the scale of the device, the place it sits in the body, and the people it is meant for.

A few images recur across the category. Implants are often photographed held between fingertips or beside a coin or a key fob, to make their size legible. X-ray-style renders show thin leads running along a spine or curving toward a nerve, with the generator drawn as a small rounded shape. Patient pages tend to use calm portraits at home, on walks or with family, rather than hospital scenes.

Brain-computer interface start-ups lean in another direction: glowing renders of the brain, electrode arrays magnified many times over, and photographs of lab benches, engineers and surgical teams. Their audience includes investors and researchers as much as doctors, and the imagery often reads as a promise about the future rather than a product shot.

The category also has its own meeting places. Trade congresses such as the North American Neuromodulation Society (NANS) meeting, the International Neuromodulation Society (INS) congress and the Society for Neuroscience annual meeting are where companies show booths, posters and new hardware to clinicians and scientists. This guide sets out what can be checked about each company — founding, ownership, products and approvals as dated sources state them — and marks clearly what rests only on the company’s own word.

A NYSE listing in 2018 and a patient-first voice.

Inspire went public in May 2018. Renaissance Capital reported on 23 April 2018 that the Maple Grove company planned to list on the New York Stock Exchange under the symbol INSP, with BofA Merrill Lynch and Goldman Sachs as joint bookrunners, and its IPO profile gives the offering date as 2 May 2018.

As a brand, Inspire addresses patients as much as surgeons. Its website leads with a “Do I Qualify?” prompt and offers a find-a-doctor service, free events, patient ambassadors and a Spanish-language section, and the company publishes a Patient Experience Report. It calls its implant “the first FDA approved obstructive sleep apnea therapy of its kind,” a claim it makes on its own website.

For a design guide, Inspire Medical Systems shows how a company focused on a single condition can build its identity around the bedroom rather than the operating theatre. Compare Medtronic, the company its technology came from, and Neuronetics, another US neurostimulation company that listed in 2018. For this guide we use a night navy, a dusk blue and a pale dawn grey with a sans, an unofficial interpretation; no product or logo is reproduced.

Keep Inspire Medical Systems’s identity on hand — save it to a board in the Made Good inspiration library.