XenMatrix™ AB Surgical Graft in Ventral or Incisional Midline Hernias

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 COPD 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 ADL, 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.