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  "documentTitle": "Inspire Medical Systems, Inc. (INSP)",
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  "presentationDate": "2020-04-22 00:00:00",
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  "notes": "The slide uses patient anecdotes and FDA data to argue against the viability and safety of the Inspire system.",
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      "text": "It really is that simple. Patients are unlikely to choose to undergo an invasive, expensive surgery with a cumbersome list of restrictions that must be followed for the rest of their life to fix a condition that generally doesn't bother them very much.",
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      "text": "adverse event rate: 2.7%",
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      "text": "Every sleep expert we spoke to highlighted that the symptoms of OSA often go unnoticed by the patient themselves. Many patients only go to the doctor for OSA because their bed partner can't tolerate the patient's snoring. The doctor often has to convince the patient that they have an “illness” at all:",
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      "text": "We include a very long list of adverse event reports from the FDA database in Appendix D. There are a disturbing number of cases of surgeons “lacerating” the jugular vein during the procedure, as well as other nightmarish, near-death stories like this one:",
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      "text": "Inspire promises patients a mask-free sleep in exchange for long list of more onerous restrictions on their everyday life. The restrictions on cell phones, power tools, computers and other technology makes it impossible for patients to resume their normal lives after surgery.",
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      "text": "She also complains that the constant electrical shocks feel like someone is “tugging and twisting” her tongue. This is a very common complaint from Inspire patients – one-third of the patients in Inspire’s STAR study complained of discomfort from the device’s electrical shocks, which are supposed to be providing the “therapy.”",
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      "text": "It really is that simple. Patients are unlikely to choose to undergo an invasive, expensive surgery with a cumbersome list of restrictions that must be followed for the rest of their life to fix a condition that generally doesn’t bother them very much.",
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      "text": "Just like Patient A, Patient B finds the device impossible to live with. She no longer turns it on at night. Both patients want to have the device removed but fear the significant risks associated with the removal surgery. So, they have simply left the device in place - a not-so-subtle reminder of what changed their lives forever.",
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      "text": "Inspire reports having done ~7,200 implants, and there have been 192 adverse events reported to the FDA as of the date of this writing, which equates to a real-world adverse event rate of ~2.7%. However, during Inspire’s initial 12-month STAR Study, when all patients were monitored and all adverse events were documented, 107 out of 126 patients (85%) suffered at least one adverse event and there were 494 total adverse events. Several medical experts we spoke to said it’s expected that many real-world adverse events would go unreported for a variety of reasons, so a real-world adverse event rate higher than 1% would be considered a major red flag to them.",
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      "text": "A lot of times patients are very reluctant to go for a surgical option. Their perception is that it’s not a very high priority or concerning medical issue... So, the number of patients who agree, who even want to discuss surgical options, is fairly low.",
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      "text": "During a surgical procedure to implant the Inspire System, shortly after putting the stimulation cuff on, the patient coded and his heart rate went down to 28. An emergency team responded in the operating room and provided treatment. Immediately after treatment, the patient's blood pressure dropped and the emergency team again provided treatment. The physician decided to end the case. The patient is currently in the ICU and should make a full recovery.",
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      "text": "\"During a surgical procedure to implant the Inspire System, shortly after putting the stimulation cuff on, the patient coded and his heart rate went down to 28. An emergency team responded in the operating room and provided treatment. Immediately after treatment, the patient's blood pressure dropped and the emergency team again provided treatment. The physician decided to end the case. The patient is currently in the ICU and should make a full recovery.\" — FDA database report; \"A lot of times patients are very reluctant to go for a surgical option. Their perception is that it's not a very high priority or concerning medical issue... So, the number of patients who agree, who even want to discuss surgical options, is fairly low.\" — Sleep Apnea expert interview, February 2020",
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      "text": "10 https://clinicaltrials.gov/ct2/show/results/NCT01161420?view=results\n11 https://clinicaltrials.gov/ct2/show/results/NCT01161420\n12 Sleep Apnea expert interview, February 2020",
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      "text": "Inspire’s surgery is bad, but the device’s restrictions are even worse",
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