TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Pilot Study

Key Inclusion Criteria:

• Subject is 18 years old or older;
• Patient willing and able to provide a signed Patient Informed Consent Form;
• Has a midline primary ventral, umbilical or incisional hernia;
• Scheduled for a laparoscopic IPOM hernia repair;
• Hernia can be successfully repaired with at least a 5 cm overlap of the mesh on all sides of the defect

Key Exclusion Criteria:

• Patient has a known or suspected hypersensitivity to the constituent polymer of the investigational device, mesh, or other surgical products (e.g., sutures);
• BMI > 40;
• Patient is a current smoker, defined as self-reporting smoking more than 1 cigarette per day;
• Patient is taking systemic immunosuppressive medications, systemic steroids, or chemotherapy at the time of informed consent;
• Patient is pregnant, plans to become pregnant during the study period, or is breastfeeding;
• Patient with Type 1 or uncontrolled Type 2 Diabetes Mellitus;
• Patient has more than one hernia defect (to be confirmed intraoperatively);