AFFIX: Post-market Study of MaxTack™ Motorized Fixation Device in Subjects Undergoing Ventral Hernia Repair

A prospective, post-market, multicenter, nonrandomized, single-arm, interventional clinical study of the MaxTack™ Motorized Fixation Device when used for fixation of prosthetic material to soft tissue in minimally invasive ventral hernia repair procedures. Subjects will be followed in the short term (1 and 3 months) and long term (12 months) to evaluate safety and performance of the device.

The study is being conducted in two phases. Phase 1 will enroll approximately 33 subjects at up to 3 sites in the United States. Based on regulatory needs, Phase 2 may enroll additional subjects at approximately 10 US sites, for a total of up to 110 subjects across both phases.

Preoperative Inclusion Criteria:

• Subject has provided informed consent (IC)
• Subject is 18 years of age or older at the time of consent
• Subject is able and willing to comply with the study requirements and follow-up schedule
• Subject is undergoing an elective, single-stage, primary or incisional ventral hernia repair
• Subject is undergoing minimally invasive ventral hernia repair procedure using the MaxTack™ Motorized Fixation Device
• 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)
• 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:

• Subject is undergoing an emergency surgery (e.g., lifesaving procedures performed where subject is in imminent danger of death, strangulated hernia, etc.)
• Subject has history of 3 or more hernia repair procedures
• Subject has existing mesh in the space where the physician needs to apply the new mesh to be fixated with the MaxTack™ Motorized Fixation Device
• Subject is scheduled (or anticipated to be scheduled) for additional surgery, and subsequent surgery would jeopardize previous application of study treatment
• Subject has history of allergic reactions to Poly (Glycolide-co-L-lActide) (PGLA)
• Subject has history of allergic reactions to the components of the intended mesh
• Subject has any systemic or local ongoing infection at the time of the surgery
• Subject has a Body Mass Index (BMI) greater than 45 kg/m2
• Subject has life expectancy in the opinion of the investigator, of less than 3 years at the time of enrollment
• Subject is pregnant (as determined by standard site practices) or is planning to become pregnant during study duration period.
• Subject has participated or will participate in an investigational drug or device research study that would interfere with the results of this study
• Subject's participation in the study may jeopardize the safety or welfare of the subject, as determined by the investigator
• Subject is already enrolled or was previously enrolled in this study

Intraoperative Exclusion Criteria:

• Subject did not receive the MaxTack™ Motorized Fixation Device tacks to fixate the mesh
• Subject did not receive a Medtronic (including Covidien) mesh
• Inability to comply with the mesh IFU
• Subject required more than a single piece of mesh
• Subject has a surgical wound classified as Class II (clean-contaminated), Class III (contaminated) or Class IV (dirty/infected) as defined by the CDC classification
• Subject with an American Society of Anesthesiologists (ASA) score of Class 4, 5, or 6
• Inability to close the hernia defect
• Subject's procedure required a multi-stage repair
• Subject's minimally invasive procedure required to convert to open