Inspire Medical Systems Inc, a medical technology company that makes an implantable therapy for obstructive sleep apnea (OSA) and is focused on the development and commercialization of minimally invasive solutions for patients with the sleep disorder, has successfully implanted a new sensing lead (model number 4340) in Europe. Dr Joachim Maurer, University Hospital, Mannheim, Germany, who has now overseen 80 Inspire therapy cases, completed the implant. 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 smaller profile, including a reduction in diameter of 49% as compared to the prior design. 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,” says Maurer, in a release. “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 US Food and Drug Administration (FDA) and, pending clearance, the company expects the product to be available in the United States in early 2019.
from Sleep Review http://www.sleepreviewmag.com/2018/10/europe-inspire-medical-implants-new-sensing-lead/