TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Pilot Study

Key Inclusion Criteria:

1. Subject is 18 years old or older;

2. Patient willing and able to provide a signed Patient Informed Consent Form;

3. Has a midline primary ventral, umbilical or incisional hernia;

4. Scheduled for a laparoscopic IPOM hernia repair;

5. Hernia can be successfully repaired with at least a 5 cm overlap of the mesh on allsides of the defect

Key Exclusion Criteria:

1. Patient has a known or suspected hypersensitivity to the constituent polymer of theinvestigational device, mesh, or other surgical products (e.g., sutures);

2. BMI > 40;

3. Patient is a current smoker, defined as self-reporting smoking more than 1 cigaretteper day;

4. Patient is taking systemic immunosuppressive medications, systemic steroids, orchemotherapy at the time of informed consent;

5. Patient is pregnant, plans to become pregnant during the study period, or isbreastfeeding;

6. Patient with Type 1 or uncontrolled Type 2 Diabetes Mellitus;

7. Patient has more than one hernia defect (to be confirmed intraoperatively);