Xen Matrix™ AB Surgical Graft in Ventral or Incisional Midline Hernias

A Post-Market, Prospective, Multicenter, Single-Arm Trial of XenMatrix™ AB Surgical Graft in All Wound Classes Ventral or Incisional Midline Hernias

This study aims to prospectively explore the use of XenMatrix™ AB Surgical Graft for ventral or incisional midline hernia repair in patients across all wound classes ("All Comers") through 24 months post repair.

This is a post-market, on-label study to understand the performance of the graft in the US.

Inclusion Criteria:

• Subject must be willing and able to give written informed consent.
• Subject must be diagnosed with a ventral or incisional midline hernia.
• Mesh must be placed in the retro-rectus or intraperitoneal plane.
• Subject must be willing to undergo open hernia repair and be able to undergo all other study procedures as outlined in this protocol.

Exclusion Criteria:

• The use of surgical graft as a bridge repair.
• The subject has more than 4 prior recurrences.
• Subject has a contraindication for the placement of surgical graft.
• Complete removal of existing mesh from a prior hernia repair (in the same affected area) is not possible.
• The study hernia repair requires more than a single piece mesh (including sufficient overlap beyond margins of the defect on all sides).
• Subject has intact permanent mesh adjacent to the current hernia to be repaired.
• Subject has peritonitis at the time of surgery.
• The subject is an active smoker within the last 2 weeks prior to surgery.
• Clinically significant Chronic Obstructive Pulmonary Disease or heart failure, defined as marked limitation in ability or inability to perform activities of daily living.
• Subject had chemotherapy within the last 12 months, is on or suspected to be placed on chemotherapy medications during any part of the study.
• Chronic steroid use (>6 months) or immunosuppression drugs.
• Subject's body mass index (BMI) >45 kg/m2.
• Subject has cirrhosis, and/or ascites.
• Subject has a defined collagen disorder.
• Known to be infected with human immunodeficiency virus (HIV).
• Subject has clinically significant (not based solely on creatinine levels) kidney disease that limits Activities of Daily Living, is on hemodialysis or peritoneal dialysis.
• Subject is American Society of Anesthesiology (ASA) Class 4 or 5.
• Subject has a life expectancy < 2 years at the time of enrollment.
• Subject is pregnant, breastfeeding or planning on becoming pregnant during the course of the study.
• Subjects with known sensitivity to porcine products.
• Subjects with allergy, history of allergy or hypersensitivity to tetracyclines (including minocycline) or rifamycins (including rifampin).
• Subject has any condition in the opinion of the Investigator that would preclude the use of the study device, or preclude the subject from completing the follow-up requirements.