Inspire Medical Systems, Inc. has published clinical outcomes data for its Inspire V system, showcasing the device's performance in treating obstructive sleep apnea (OSA). The data was presented at the American Otolaryngology-Head and Neck Surgery (AAO-HNS) and International Surgical Sleep Society (ISSS) meetings. The company's Chairman and CEO, Tim Herbert, highlighted the Inspire V system's success in achieving high and consistent patient adherence of over six hours per night.
In the Singapore clinical study, 44 patients received the Inspire V system, with the results showing a 20% reduction in surgical times compared to the prior generation, as well as 100% successful procedure completion. The Inspire V system demonstrated superior performance in inspiratory phase overlap percentage (ipop) compared to the previous generation, with an ipop of 87.1% versus 79.4% for Inspire IV.
Moreover, the Inspire V system showcased strong safety profiles, with only two patients requiring post-operative antibiotics for wound care, which resolved within two weeks following the procedure. The study also revealed impressive patient adherence to therapy, with all 44 patients averaging 5.5±1.7 hours of therapy per night at a mean of 246 days post-implant.
In the limited market release evaluation in the United States, 101 patients received the Inspire V system, with all procedures completed successfully and no serious adverse events reported. At the 60-day check, all patients were using their therapy with an average stimulation amplitude of 1.7 volts and an average usage of 6.8 hours per night.
The Inspire V system also showed promising results in reducing the apnea hypopnea index (AHI), with data from the first 34 patients demonstrating a median reduction from 30 to 4.5 events per hour. The system maintained consistent therapy adherence at 6.7 hours per night with an average amplitude of 1.7 volts.
The limited market release also provided insights from single-site results, with Dr. Phil Huyett reporting an average surgical implant time of 34.5 minutes for a standard Inspire V placement. Dr. Nic Beckmann at Colorado ENT and Allergy in Colorado Springs noted an increase in implant volume with Inspire V due to shorter procedure times, averaging 12 implants per surgery day compared to an average of 9 cases per surgery day with Inspire IV.
The data presented at the meetings showcased the significant advancements with the Inspire V system, demonstrating its potential to provide effective and minimally invasive solutions for patients with OSA. Today the company's shares have moved -6.2% to a price of $75.17. For the full picture, make sure to review Inspire Medical Systems's 8-K report.
