Post-Procedure Discomfort and Complications Quiz
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Questions and Answers

According to the FDA Summary of Safety and Effectiveness Data, what percentage of subjects with baseline AHI had serious adverse events during the follow-up period?

  • 2.8% (correct)
  • 0.7%
  • 29.1%
  • 3.7%

    • Which adverse event had the highest percentage among subjects with baseline AHI during the follow-up period?

  • Stimulation related discomfort (correct)
  • Unspecified
  • Other device/therapy related event
  • Insomnia/arousal

    • What was the percentage of subjects with baseline AHI who had non-serious adverse events during the follow-up period?

  • 2.8%
  • 12.2%
  • 35.0%
  • 27.2% (correct)

    • Which adverse event had the highest percentage among subjects with baseline AHI during the procedure?

    <p>Revisions</p> Signup and view all the answers

    Which adverse event had the highest percentage of subjects with events?

    <p>Pneumothorax</p> Signup and view all the answers

    Which adverse event had the lowest percentage of subjects with events?

    <p>Ecchymosis</p> Signup and view all the answers

    How many subjects experienced lip weakness?

    <p>1</p> Signup and view all the answers

    Which company is the applicant for the Inspire Upper Airway Stimulation System?

    <p>Inspire Medical Systems, Inc.</p> Signup and view all the answers

    What is the indication for use of the Inspire Upper Airway Stimulation (UAS) system?

    <p>To treat a subset of patients with moderate to severe obstructive sleep apnea (OSA)</p> Signup and view all the answers

    What is the purpose of Supplement P130008/S090?

    <p>To update the BMI warning for the Inspire UAS system</p> Signup and view all the answers

    Which device is used to stimulate the hypoglossal nerve to open the upper airway?

    <p>Model 4323</p> Signup and view all the answers

    What is the purpose of the sensing lead in the intercostal space?

    <p>To detect respiratory signals</p> Signup and view all the answers

    Which device allows the physician to noninvasively interrogate and configure the IPG settings?

    <p>Model 2740</p> Signup and view all the answers

    Which alternative is mentioned for the correction of obstructive sleep apnea in patients with AHI>65 and/or BMI ≥40 who have failed or are intolerant of PAP?

    <p>Both A and B</p> Signup and view all the answers

    Based on the data provided, what percentage of patients with AHI>65 were included in the analysis to support expanding the indication of the Inspire UAS system?

    <p>3.7%</p> Signup and view all the answers

    What was the average final AHI for patients with AHI>65?

    <p>18.77</p> Signup and view all the answers

    What was the average change in AHI from baseline to final for patients with AHI>65?

    <p>11.9</p> Signup and view all the answers

    What was the responder rate for patients with AHI>65?

    <p>66.7%</p> Signup and view all the answers

    Which patients are eligible for treatment with the Inspire UAS system?

    <p>Patients with complete concentric collapse at the soft palate level</p> Signup and view all the answers

    What is the definition of PAP intolerance?

    <p>Inability to use PAP (greater than 5 nights per week of usage; usage defined as greater than 4 hours of use per night)</p> Signup and view all the answers

    What are the contraindications for using the Inspire UAS system?

    <p>All of the above</p> Signup and view all the answers

    What are the components of the Inspire UAS system?

    <p>Implantable pulse generator (IPG), stimulation lead and sensing lead, physician programmer and patient remote</p> Signup and view all the answers

    Which adverse event had the highest percentage among subjects with events?

    <p>Pneumothorax</p> Signup and view all the answers

    How many subjects experienced tongue discomfort/irritation?

    <p>2</p> Signup and view all the answers

    What was the percentage of subjects with events for the adverse event 'Chest pain'?

    <p>0.1%</p> Signup and view all the answers

    Based on the data provided, what percentage of patients with baseline AHI>65 were included in the analysis to support expanding the indication of the Inspire UAS system?

    <p>1.4%</p> Signup and view all the answers

    What was the average age of patients included in the analysis to support expanding the indication of the Inspire UAS system to patients with baseline AHI>65?

    <p>60.14 years</p> Signup and view all the answers

    What was the average BMI of patients included in the analysis to support updating the BMI warning?

    <p>28.99</p> Signup and view all the answers

    What was the responder rate for patients with baseline AHI>65?

    <p>66.7%</p> Signup and view all the answers

    Which age group is included in the expanded indications for the Inspire UAS system?

    <p>All patients with obstructive sleep apnea</p> Signup and view all the answers

    What is the range of the apnea-hypopnea index (AHI) for patients eligible for treatment with the Inspire UAS system?

    <p>Greater than or equal to 15 and less than or equal to 100</p> Signup and view all the answers

    What is the indication for use of the Inspire Upper Airway Stimulation (UAS) system?

    <p>To treat a subset of patients with moderate to severe obstructive sleep apnea (OSA)</p> Signup and view all the answers

    Based on the information provided, what was the average final AHI for patients with AHI>65?

    <p>C. 50</p> Signup and view all the answers

    According to the text, what is the definition of PAP intolerance?

    <p>D. Inability to tolerate continuous positive airway pressure therapy</p> Signup and view all the answers

    Among subjects with baseline AHI, which adverse event had the highest percentage during the follow-up period?

    <p>C. Dry mouth</p> Signup and view all the answers

    What is the purpose of Supplement P130008/S090?

    <p>A. To evaluate the safety and effectiveness of a medical device</p> Signup and view all the answers

    Which company is the applicant for the Inspire Upper Airway Stimulation System?

    <p>Company B</p> Signup and view all the answers

    What is the definition of PAP intolerance?

    <p>Inability to tolerate positive airway pressure therapy</p> Signup and view all the answers

    What are the components of the Inspire UAS system?

    <p>Upper airway sensor, nasal mask, and remote control</p> Signup and view all the answers

    How many subjects experienced lip weakness?

    <p>30</p> Signup and view all the answers

    Which device is used to stimulate the hypoglossal nerve to open the upper airway?

    <p>Model 2500 Sleep Remote</p> Signup and view all the answers

    What are the components of the Inspire UAS system?

    <p>Model 4323 Sensing Lead, Model 4340 Sensing Lead</p> Signup and view all the answers

    What is the indication for use of the Inspire Upper Airway Stimulation (UAS) system?

    <p>Treatment of obstructive sleep apnea in patients with AHI&gt;65 and/or BMI ≥40 who have failed or are intolerant of PAP</p> Signup and view all the answers

    What is the purpose of the sensing lead in the intercostal space?

    <p>To detect respiratory signals</p> Signup and view all the answers

    According to the FDA Summary of Safety and Effectiveness Data, what is the indication for use of the Inspire Upper Airway Stimulation (UAS) system?

    <p>Treatment of adult patients 22 years of age and older who have failed or cannot tolerate PAP treatments</p> Signup and view all the answers

    What are the contraindications for using the Inspire UAS system?

    <p>All of the above</p> Signup and view all the answers

    Which device is used to stimulate the hypoglossal nerve to open the upper airway?

    <p>Implantable pulse generator (IPG)</p> Signup and view all the answers

    What is the purpose of the sensing lead in the intercostal space?

    <p>To detect the patient's respiratory effort</p> Signup and view all the answers

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