Globe Newswire11.12.18
Inspire Medical Systems Inc., a medical technology company focused on the development and commercialization of minimally invasive solutions for patients with obstructive sleep apnea (OSA), announced the first implant of its new sensing lead (model number 4340) in Europe. The implant was successfully completed by Dr. Joachim Maurer, University Hospital, Mannheim, Germany, who has now overseen 80 Inspire therapy cases. Dr. Maurer is an ear, nose and throat (ENT) surgeon and head of the Sleep Disorders Center.
The sensing lead monitors a patient’s respiratory pattern as the implanted Inspire system delivers stimulation to the upper airway in order to prevent obstructions during sleep. The new 4340 sensing lead has a significantly smaller profile, including a reduction in diameter of 49 percent, as compared to the prior design. This diminished profile improves patient comfort. The new design also incorporates several features to enhance the ease of implant and reduce surgical time for an ENT surgeon.
“We are pleased to have successfully completed the first case in Europe incorporating the new sensing lead for Inspire therapy,” said Dr. Maurer. "The improved features of the sensing lead led to a simpler implant procedure. We continue to view Inspire therapy as a safe and effective treatment for OSA.”
Inspire intends to introduce the new sensing lead to other centers in Europe in the near future. Currently, the 4340 sensing lead is under review by the U.S. Food and Drug Administration (FDA) and, pending clearance, the company expects the product to be available in the United States in early 2019.
Inspire is a medical technology company focused on the development and commercialization of innovative and minimally invasive solutions for patients with obstructive sleep apnea. Inspire’s proprietary Inspire therapy is the first and only FDA-approved neurostimulation technology that provides a safe and effective treatment for moderate to severe obstructive sleep apnea.
The sensing lead monitors a patient’s respiratory pattern as the implanted Inspire system delivers stimulation to the upper airway in order to prevent obstructions during sleep. The new 4340 sensing lead has a significantly smaller profile, including a reduction in diameter of 49 percent, as compared to the prior design. This diminished profile improves patient comfort. The new design also incorporates several features to enhance the ease of implant and reduce surgical time for an ENT surgeon.
“We are pleased to have successfully completed the first case in Europe incorporating the new sensing lead for Inspire therapy,” said Dr. Maurer. "The improved features of the sensing lead led to a simpler implant procedure. We continue to view Inspire therapy as a safe and effective treatment for OSA.”
Inspire intends to introduce the new sensing lead to other centers in Europe in the near future. Currently, the 4340 sensing lead is under review by the U.S. Food and Drug Administration (FDA) and, pending clearance, the company expects the product to be available in the United States in early 2019.
Inspire is a medical technology company focused on the development and commercialization of innovative and minimally invasive solutions for patients with obstructive sleep apnea. Inspire’s proprietary Inspire therapy is the first and only FDA-approved neurostimulation technology that provides a safe and effective treatment for moderate to severe obstructive sleep apnea.