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

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-upschedule

4. Subject is undergoing an elective, single-stage, primary or incisional ventralhernia repair

5. Subject is undergoing minimally invasive ventral hernia repair procedure using theMaxTack™ Motorized Fixation Device

6. Subject is undergoing minimally invasive ventral hernia repair procedure using aMedtronic (including Covidien) mesh that is intended to be used in compliance withthe mesh Instructions for Use (IFU)

7. Subject is expected to meet the criteria for a class I wound (clean) as defined byCenters for Disease Control and Prevention (CDC) classification

Preoperative Exclusion Criteria:

1. Subject is undergoing an emergency surgery (e.g., lifesaving procedures performedwhere subject is in imminent danger of death, strangulated hernia, etc.)

2. Subject has history of 3 or more hernia repair procedures

3. Subject has existing mesh in the space where the physician needs to apply the newmesh to be fixated with the MaxTack™ Motorized Fixation Device

4. Subject is scheduled (or anticipated to be scheduled) for additional surgery, andsubsequent surgery would jeopardize previous application of study treatment

5. Subject has history of allergic reactions to Poly (Glycolide-co-L-lActide) (PGLA)

6. Subject has history of allergic reactions to the components of the intended mesh

7. Subject has any systemic or local ongoing infection at the time of the surgery

8. Subject has a Body Mass Index (BMI) greater than 45 kg/m2

9. Subject has life expectancy in the opinion of the investigator, of less than 3 yearsat the time of enrollment

10. Subject is pregnant (as determined by standard site practices) or is planning tobecome pregnant during study duration period.

11. Subject has participated or will participate in an investigational drug or deviceresearch study that would interfere with the results of this study

12. Subject's participation in the study may jeopardize the safety or welfare of thesubject, as determined by the investigator

13. Subject is already enrolled or was previously enrolled in this study

Intraoperative Exclusion Criteria:

1. Subject did not receive the MaxTack™ Motorized Fixation Device tacks to fixate themesh

2. Subject did not receive a Medtronic (including Covidien) mesh

3. Inability to comply with the mesh IFU

4. Subject required more than a single piece of mesh

5. 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

6. Subject with an American Society of Anesthesiologists (ASA) score of Class 4, 5, or 6

7. Inability to close the hernia defect

8. Subject's procedure required a multi-stage repair

9. Subject's minimally invasive procedure required to convert to open