Study of Phasix™ Mesh for VHWG Grade 3 Midline Hernia Repair

A Post-Market, Prospective, Multi-Center, Single-Arm Clinical Investigation of Phasix™ Mesh for VHWG Grade 3 Midline Hernia Repair

The purpose of this study is to collect additional data on safety and performance of Phasix™ Mesh in subjects requiring Ventral Hernia Working Group (VHWG) Grade 3 midline hernia repair.

Approximately 85 subjects, at approximately 12 sites across Europe will be enrolled and treated to study the use of Phasix™ Mesh. All treated subjects will be followed for 2 years post-implantation.

Inclusion Criteria:

• Subject must be diagnosed with incisional midline hernia.
• Subject has a VHWG Grade 3 hernia (as defined in the protocol).
• Size of hernia ≥ 10 cm2.
• Subject must be willing to undergo a planned retro-rectus hernia repair (onlay allowed as an exception when retro-rectus placement cannot be achieved; using absorbable suture) with or without Component Separation Technique.

Exclusion Criteria:

• Subject with > 4 previous repairs of the hernia under observation.
• Body Mass Index (BMI) > 35 kg/m2.
• The subject is on, or suspected to be placed on, chemotherapy medications during any part of the study.
• The subject has peritonitis.
• Known human immunodeficiency virus (HIV) infection (if documented in the subject's record).
• The subject has cirrhosis of the liver and/or ascites.
• Subject is American Society of Anesthesiology Class 4 or 5.
• Complete removal of existing mesh from a prior hernia repair (in the same affected area) is not possible.
• The hernia repair requires more than a single piece mesh (with adequate overlap beyond the margins of the defect on all sides).
• Subject has intact permanent mesh adjacent to the current hernia to be repaired.
• Subject's hernia repair requires intraabdominal mesh placement.
• Surgical technique requires surgical bridge repair as the sole repair.
• Subject has any condition that, in the opinion of the Investigator, would preclude the use of the study device, or preclude the subject from completing the follow-up requirements.
• Subject is pregnant or has plans to become pregnant during the study period or is currently breastfeeding.
• Subject has an alcohol/substance abuse problem or has had a relapse within 12 months of the screening visit.
• Subject was involved in another interventional clinical study in the last 30 days prior to Informed Consent Form (ICF) signature.
• Subject is part of the site personnel directly involved with this study.
• Subject has a life expectancy of less than 2 years at the time of enrollment.
• Subject has a known sensitivity to Phasix™ Mesh or component materials (patients with known allergies to tetracycline hydrochloride or kanamycin sulfate should be avoided).