Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®

Exclusion Criteria20

• Patient has a Body Mass Index (BMI) of ≥ 35.
• Patient meets the Centers for Disease Control (CDC) Surgical Site Infection (SSI) Wound Classification Class IV (Dirty-Infected) criteria.
• Patient has a Type I hiatal hernia (defined as only the esophagogastric junction is above the diaphragm).
• Patient has a life expectancy of less than five years making it unlikely that the subject will successfully achieve five-year follow-up.
• Patient is a current nicotine user (including smokeless, vaporized, etc.)
• Patient has a history of illicit drug or alcohol abuse (in the last three years).
• Patient has an allergy to ovine-derived products or a known sensitivity to polyglycolic acid (PGA).
• Patient has an allergy to barium.
• Patient's surgery will include the use of an anti-reflux implantable device (LINX, etc.).
• Patient's surgery requires the use of an additional mesh device or a pledget for reinforcement.
• Patient has participated in another gastrointestinal (GI) clinical study within the past 30 days or is currently involved in another clinical study excluding observational and registry studies.
• Patient had previous surgery at the gastroesophageal junction.
• Patient had a prior hiatal hernia repair.
• Patient has an incarcerated hernia that requires emergent intervention.
• Patient is a prisoner.
• Patient is unable to receive OviTex Core Resorbable or OviTex 1S Resorbable at time of surgery.
• Surgery requires the use of an additional mesh device or a pledget for reinforcement.
• Surgery includes the use of an anti-reflux implantable device (LINX, etc.).
• Surgery performed as an open procedure.
• Patient has a condition, which in the Investigator's opinion, may put the patient at increased risk, confound study data, or interfere significantly with the patient's participation in the study.