Miromatrix Biological Mesh for Hiatal Hernia Repair

Inclusion Criteria:

- between 18 and 80 years old on the day of study enrollment

- able and willing to sign the consent form and comply with all study visits and
procedures

- able to undergo elective laparoscopic hiatal hernia repair

- free of cognitive or speech impairment

- documented, symptomatic type II or III hernia ≥5cm in the axial/vertical dimension

- commit to non-smoking for at least 4 weeks prior to procedure

Exclusion Criteria:

- previous operation of the esophagus or stomach

- sensitivity to porcine material

- pregnant or plan to be pregnant within next 2 years

- immunocompromised or at risk of immunosuppression (i.e. be HIV positive, be
experiencing organ rejection, be a recent or anticipated chemotherapy recipient) as
determined by the Investigator

- require emergent operation for acute gastric volvulus or strangulation

- American Society of Anesthesiology (ASA) class 4 or greater

- BMI ≥40

- life expectancy of less than 2 years at the time of enrollment

- associated gastrointestinal disease that requires extensive medical or surgical
intervention that might interfere with the quality of life assessment (e.g. Crohn's
disease)

- 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