Transorb™ Self-Gripping Resorbable Mesh in High-risk Subjects Undergoing Open Repair of Ventral Hernia

Eligibility Criteria

• 1. Subject has provided informed consent
• 2. Subject is 18 years of age or older at the time of consent
• 3. Subject is undergoing a planned, elective, open, single-staged repair of a midline primary or incisional ventral hernia using retrorectus/retromuscular mesh placement with or without Transversus Abdominis Release (TAR)
• 4. Subject is expected to meet the criteria for:
• 1. In the US: a class I / clean wound as defined by the CDC (Centers for Disease Control and Prevention) wound classification
• 2. In Europe: a class I / clean wound or a class II / clean-contaminated wound as defined by the CDC wound classification in compliance with these conditions:
• * No break in the sterile technique, and
• * Entry into gastrointestinal tract with no or minimal spillage
• 5. Subject has at least one of the following comorbid factors impairing wound healing:
• 1. Current smokers (subject who has smoked 100 cigarettes in his or her lifetime and who currently smokes) Note: Use smoking status prior to preoperative optimization for inclusion assessment.
• 2. Smokers with a minimum 20 pack year history (including former smokers)
• 3. Obesity, defined as body Mass Index (BMI) between 30kg/m2 and 39.9kg/m2
• 4. Chronic Obstructive Pulmonary Disease (COPD)
• 5. Diabetes mellitus
• 6. History of wound infection
• 7. Malnutrition (serum albumin less than 3.4 g/d)
• 8. Coronary Artery Disease (CAD)
• 9. History of chemotherapy
• 10. Diagnosis of hypertension
• 11. History of malignancy without evidence of active disease
• 12. Renal insufficiency (serum creatinine concentration ≥2.5 mg/d)
• 1. Subject is involved in another interventional drug or device study
• 2. Subject is unable or unwilling to comply with the study requirements or follow-up schedule
• 3. Subject has a history of:
• 1. Previous hernia repair involving retrorectus/retromuscular mesh placement or a component separation technique (CST)
• 2. Allergic reactions to products with PLLA/TMC (Poly-L-lactide, poly-trimethylene carbonate copolymer)
• 3. Solid organ transplantation
• 4. Subject has current diagnosis/usage of:
• 1. BMI greater than or equal to 40.0 kg/m2
• 2. Human Immunodeficiency Virus (HIV)
• 3. Collagen formation disorder (such as Ehlers-Danlos syndrome and Marfan's syndrome)
• 4. Liver cirrhosis and/or current ascites
• 5. Renal disease requiring dialysis
• 6. Bleeding disorder and/or cannot be removed from anticoagulants prior to surgery based on surgeon discretion and standard-of-care (excluding aspirin)
• 7. Chronic immunosuppression therapy (10 mg or greater of prednisone or equivalence/ day)
• 8. Current or anticipated chemotherapy/radiotherapy during study period
• 9. Stoma
• 10. Any systemic or local ongoing infection that is uncontrolled and/or requiring treatment such as antimicrobial medication (Note: other uses of antimicrobial medications not excluded)
• 5. Subject has life expectancy of less than 5 years based on the judgement of investigator
• 6. Subject is pregnant or is planning pregnancy within the 60-month follow-up period (females of childbearing potential will be required to provide either a urine or serum pregnancy test, except for subjects who are surgically sterile, or are at least 2 years post-menopausal)
• 7. Subject is breastfeeding or is planning to breastfeed during the study duration period
• 8. Subject has any other medical condition that precludes the subject from participation, in the opinion of the investigator
• 9. Subject is undergoing:
• 1. Minimally invasive hernia repair (i.e., laparoscopic or robotic surgery)
• 2. An emergency surgery (i.e., lifesaving procedures performed where subject is in imminent danger of death)
• 3. Multi-stage hernia repair
• 4. Parastomal hernia repair
• 5. Concomitant ostomy (creation or closure)
• 6. Any other additional anticipated surgery, if subsequent surgery that would jeopardize previous application of study device, in the opinion of the investigator
• 10. Subject is American Society of Anesthesiology Class 4, 5, or 6
• 11. Subject has a BMI greater than or equal 40.0 kg/m2
• 12. Subject is pregnant or is planning pregnancy within the 60-month follow-up period (females of childbearing potential will be required to provide either a urine or serum pregnancy test, except for subjects who are surgically sterile, or are at least 2 years post-menopausal)
• 1. Subject has existing mesh from previous ventral hernia surgery that investigator was unable to completely remove
• 2. Subject has concomitant diastasis (\>2 cm) that was not repaired
• 3. Hernia defect that will require a multi-stage repair
• 4. Subject no longer meets Inclusion Criteria 4
• 5. Subject who will require more than a single piece of Transorb™ or any other additional mesh
• 6. Subject with anticipated inability to achieve both:
• 1. Midline anterior and posterior rectus fascia closure without excessive tension, and
• 2. Skin closure
• 7. Subject who is otherwise no longer eligible to receive Transorb™ in open retrorectus/retromuscular position with or without Transversus Abdominis Release (TAR).