Feasibility Study of the ReVENT Sleep Apnea System

Feasibility Study of the ReVENT Sleep Apnea System for the Treatment of Obstructive Sleep Apnea (OSA)

This is a prospective, multi-center, single arm, feasibility study to evaluate the safety and effectiveness of the ReVENT Sleep Apnea System for the treatment of Obstructive Sleep Apnea.

Inclusion Criteria:

• Diagnosis of OSA with AHI 15-40
• Body Mass Index (BMI) ≤ 32
• Refused or failed Continuous Positive Airway Pressure (CPAP)
• Evidence of airway collapse at soft palate and/or base of tongue

Exclusion Criteria:

• Prior OSA surgery
• Anatomy unable to accommodate implants
• Chronic immunosuppressive therapy or known problems with wound healing
• Type I or II diabetes
• Active systemic infection
• Pregnancy
• Other major medical conditions that could confound outcome measures or interfere with study completion