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

The primary objective of the study is to evaluate the performance (hernia clinical recurrence rate) of Transorb™ mesh within 12 months post-operatively when the mesh is used for repair of open ventral hernia.

The secondary objectives of the study are to evaluate the safety and performance of Transorb™ mesh when used for repair of open ventral hernia within 60 months post-operatively.

Inclusion criteria

• Subject has provided informed consent
• Subject is 18 years of age or older at the time of consent
• 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)
• Subject is expected to meet the criteria for:

• In the US: a class I / clean wound as defined by the CDC (Centers for Disease Control and Prevention) wound classification
• 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
• Subject has at least one of the following comorbid factors impairing wound healing:

• 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.
• Smokers with a minimum 20 pack year history (including former smokers)
• Obesity, defined as body Mass Index (BMI) between 30kg/m2 and 39.9kg/m2
• Chronic Obstructive Pulmonary Disease (COPD)
• Diabetes mellitus
• History of wound infection
• Malnutrition (serum albumin less than 3.4 g/d)
• Coronary Artery Disease (CAD)
• History of chemotherapy
• Diagnosis of hypertension
• History of malignancy without evidence of active disease
• Renal insufficiency (serum creatinine concentration ≥2.5 mg/d)

Pre-Operative Exclusion Criteria Assessed during subject screening:

• Subject is involved in another interventional drug or device study
• Subject is unable or unwilling to comply with the study requirements or follow-up schedule
• Subject has a history of:

• Previous hernia repair involving retrorectus/retromuscular mesh placement or a component separation technique (CST)
• Allergic reactions to products with PLLA/TMC (Poly-L-lactide, poly-trimethylene carbonate copolymer)
• Solid organ transplantation
• Subject has current diagnosis/usage of:

• BMI greater than or equal to 40.0 kg/m2
• Human Immunodeficiency Virus (HIV)
• Collagen formation disorder (such as Ehlers-Danlos syndrome and Marfan's syndrome)
• Liver cirrhosis and/or current ascites
• Renal disease requiring dialysis
• Bleeding disorder and/or cannot be removed from anticoagulants prior to surgery based on surgeon discretion and standard-of-care (excluding aspirin)
• Chronic immunosuppression therapy (10 mg or greater of prednisone or equivalence/ day)
• Current or anticipated chemotherapy/radiotherapy during study period
• Stoma
• 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)
• Subject has life expectancy of less than 5 years based on the judgement of investigator
• 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)
• Subject is breastfeeding or is planning to breastfeed during the study duration period
• Subject has any other medical condition that precludes the subject from participation, in the opinion of the investigator
• Subject is undergoing:

• Minimally invasive hernia repair (i.e., laparoscopic or robotic surgery)
• An emergency surgery (i.e., lifesaving procedures performed where subject is in imminent danger of death)
• Multi-stage hernia repair
• Parastomal hernia repair
• Concomitant ostomy (creation or closure)
• Any other additional anticipated surgery, if subsequent surgery that would jeopardize previous application of study device, in the opinion of the investigator

Pre-Operative Exclusion Criteria assessed/confirmed on day of surgery:

• Subject is American Society of Anesthesiology Class 4, 5, or 6
• Subject has a BMI greater than or equal 40.0 kg/m2
• 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)

Intraoperative Exclusion Criteria Assessed by investigator following reduction of hernia and preparation of the retrorectus/ retromuscular space for mesh placement:

• Subject has existing mesh from previous ventral hernia surgery that investigator was unable to completely remove
• Subject has concomitant diastasis (>2 cm) that was not repaired
• Hernia defect that will require a multi-stage repair
• Subject no longer meets Inclusion Criteria 4
• Subject who will require more than a single piece of Transorb™ or any other additional mesh
• Subject with anticipated inability to achieve both:

• Midline anterior and posterior rectus fascia closure without excessive tension, and
• Skin closure
• Subject who is otherwise no longer eligible to receive Transorb™ in open retrorectus/retromuscular position with or without Transversus Abdominis Release (TAR).