AFFIX: Post-market Study of MaxTack™ Motorized Fixation Device in Subjects Undergoing Ventral Hernia Repair
Trial Parameters
Brief Summary
Medtronic is sponsoring and funding the AFFIX study, a prospective, post-market, multicenter, nonrandomized, single-arm, interventional clinical study. The purpose of this study is to evaluate the performance and safety of the MaxTack™ Motorized Fixation Device when used for fixation of prosthetic material to soft tissue in minimally invasive ventral hernia repair procedures.
Eligibility Criteria
Preoperative Inclusion Criteria: 1. Subject has provided informed consent (IC) 2. Subject is 18 years of age or older at the time of consent 3. Subject is able and willing to comply with the study requirements and follow-up schedule 4. Subject is undergoing an elective, single-stage, primary or incisional ventral hernia repair 5. Subject is undergoing minimally invasive ventral hernia repair procedure using the MaxTack™ Motorized Fixation Device 6. Subject is undergoing minimally invasive ventral hernia repair procedure using a Medtronic (including Covidien) mesh that is intended to be used in compliance with the mesh Instructions for Use (IFU) 7. Subject is expected to meet the criteria for a class I wound (clean) as defined by Centers for Disease Control and Prevention (CDC) classification Preoperative Exclusion Criteria: 1. Subject is undergoing an emergency surgery (e.g., lifesaving procedures performed where subject is in imminent danger of death, strangulated hernia, etc.) 2. Sub