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Category Archives: Inspire Medical

Implantable medical devices by Inspire Medical

GLP-1 drugs competing with implantable devices

Posted on by Posted in AIMD Business, Inspire Medical, Sleep Apnea

Image Credit: Inspire Medical

This week Inspire’s shares dropped by 32% after it cut its full-year sales outlook by $42.5M below the outlook Inspire issued three months ago.  Inspire also expected income to be in the range of 40 to 50 cents a share, well below its previous guidance for $2.20 to $2.30 per share.

Inspire blamed the slower-than-expected rollout of Inspire’s new Inspire V system and the disclosure that patients may be delaying implant of the Inspire device as they first try GLP-1 weight-loss drugs, some of which are now approved by FDA to treat obstructive sleep apnea.

Obesity is a cause of a number of diseases that are now treated with implantable medical devices. It is no surprise that GLP-1 drugs, which have gained enormous popularity for their effectiveness in weight loss, would be seen by patients and medical providers alike as a first alternative to using invasive devices.

I believe that this trend will impact the AIMD industry as GLP-1 drugs (which are not without major downsides) take precedence ahead of implantable devices in the treatment of hypertension, cardiovascular diseases, neurological diseases, and autoimmune diseases.

 

DOJ Investigating Inspire Medical for Medicare/Medicaid False Claims

Posted on by Posted in AIMD Business, Inspire Medical, Sleep Apnea

Image Credit: Inspire Medical

Inspire Medical disclosed that it is being investigated by the Department of Justice for allegations of false Medicare and Medicaid reimbursement claims.

Their latest SEC 10k filing explains:

“On January 17, 2025, we received a civil investigative demand (“CID”) from the Department of Justice U.S. Attorney’s Office for the District of Minnesota pursuant to the False Claims Act in the course of the government’s investigation concerning allegations of false claims, including false claims arising from violations of the Anti-Kickback Statute, submitted to government payors in connection with our implant. The CID requests information relating to the marketing, promotion and reimbursement practices associated with our products. We are cooperating with the investigation”

 

FDA recalls 32 Inspire model 3028 IPGs

Posted on by Posted in Inspire Medical, Neural Stimulation, Obstructive Sleep Apnea, Sleep Apnea

Image Credit: Inspire Medical

FDA has recalled 32 Inspire IV model 3028 IPGs due to a manufacturing defect which can cause system malfunctions after implantation, leading to electrical leakage in the sensing circuit. As a result, patients may need revision surgery to replace the neurostimulator IPG and restore therapy for obstructive sleep apnea.

According to the recall announcement:

“The use of affected product may cause serious adverse health consequences, including stimulation below normal therapeutic levels and/or early depletion of the battery (resulting in – loss of therapy), inappropriate or inconsistent stimulation effect, painful stimulation or perceived shocking sensation and death.

There have been no reported injuries. There have been no reports of death.”

The Bioelectronic Medicine Therapy Landscape

Posted on by Posted in Amber Therapeutics, Axonics, Bluewind Medical, Boomerang Medical, CVRx, Inspire Medical, Medipace Inc., Medtronic, Neuspera, Orchestra Biomedical, Respicardia, SetPoint Medical, Zoll
bioelectronic medicine therapies landscape

Image Credit: Victor Pikov, Ph.D., Medipace Inc.

Victor Pikov, Medipace’s founder and CEO, presented the OpenNerve Project at the First Workshop on Active Implantable Medical Devices last week.  As part of his excellent presentation, he discussed the current commercial landscape of bioelectronic medicine therapies.  A picture (in this case, the graph above) is worth a thousand words.

 

Inspire Medical’s IPG for the Treatment of Sleep Apnea

Posted on by Posted in Inspire Medical, Sleep Apnea

Image credit: Inspire Medical

Inspire Medical Systems, based in Minneapolis, Minnesota, develops implantable neurostimulation systems to treat Obstructive Sleep Apnea (OSA).  Inspire Medical Systems was formed when the Inspire intellectual property and technology was licensed and spun out from Medtronic in 2007.

Inspire therapy is designed to deliver physiologically-timed, mild stimulation to the hypoglossal nerve on each breathing cycle to prevent airway obstruction during sleep.

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