title: A novel implantable device for the treatment of obstructive sleep apnea: clinical safety and feasibility.
abstract: OBJECTIVE
  Many cases of obstructive sleep apnea (OSA) involve collapse of the tongue base and soft palate during sleep, causing occlusion of the upper airway and leading to oxygen desaturation. Existing therapies can be effective, but they are plagued by patient adherence issues and the invasiveness of surgical approaches. A new, minimally invasive implant for OSA has been developed, which is elastic and contracts a few weeks after deployment, stabilizing the surrounding soft tissue. The device has had good outcomes in preclinical testing; this report describes the preliminary feasibility and safety of its implementation in humans.
  
  
  METHODS
  A prospective, multicenter, single-arm feasibility study was conducted. Subjects were adults with moderate-to-severe OSA who had previously failed or refused conventional continuous positive airway pressure treatment. Intraoperative feasibility data, postoperative pain, and safety information were collected for a 30-day postoperative period.
  
  
  RESULTS
  Forty subjects participated (37 men, three women; average age of 46.1 years); each received two tongue-base implants and two soft-palate implants. Surgical procedure time averaged 43 minutes. Postsurgical pain resolved readily in most cases; at 30 days post implantation, <20% of subjects reported pain, which averaged less than two out of ten. Adverse events were generally the mild and expected sequelae of a surgical procedure with general anesthesia and intraoral manipulation. The device was well tolerated. Implant extrusions were reported with soft-palate implants (n=12), while tongue-base implants required few revisions (n=2). Quantitative and qualitative sleep effectiveness outcomes (including full-night polysomnographic and quality-of-life measures) will be presented in a subsequent report.
  
  
  CONCLUSIONS
  Implantation of the device was feasible. Although a relatively high rate of extrusions occurred in the now-discontinued palate implants, tongue-base implants were largely stable and well tolerated. The minimally invasive and maintenance-free implant may provide a new alternative to higher morbidity surgical procedures.
authors.affiliation: LENTE Clinic, Plzeň, Czech Republic; Faculty of Health Studies of West Bohemia University, Plzeň, Czech Republic.
authors.forename: Vaclav
authors.initials: V
authors.lastname: Pavelec
authors.affiliation: Department of Otolaryngology, Head and Neck Surgery, Western University, London, ON, Canada.
authors.forename: Brian W
authors.initials: BW
authors.lastname: Rotenberg
authors.affiliation: Department of Otorhinolaryngology, Head and Neck Surgery, University Medicine Mannheim, Mannheim, Germany.
authors.forename: Joachim T
authors.initials: JT
authors.lastname: Maurer
authors.affiliation: ReVENT Medical, Inc., Newark, CA, USA.
authors.forename: Edward
authors.initials: E
authors.lastname: Gillis
authors.affiliation: Department of Otorhinolaryngology, Head and Neck Surgery, Asklepios Klinikum Harburg, Hamburg, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Verse
keywords: breathing; implantable device; obstructive sleep apnea; sleep; surgical treatment; tongue base