Miromatrix Medical has developed MIROMESH® - a new, noncrosslinked, acellular mesh derived from the highly vascularized porcine liver. MIROMESH received FDA 510(k) clearance with an indication for reinforcement of soft tissue on March 31, 2014 under K134033. This study will serve to provide clinicians with high-quality clinical data in order to provide them with a higher degree of confidence when selecting MIROMESH for hiatal hernia repair.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
University of Kentucky
Lexington, Kentucky, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
Carolinas Healthcare System
Charlotte, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Number of Subjects With a Hernia Recurrence Requiring Reoperation
Failure of the index hernia operation which requires another operative procedure to correct. Hernia recurrence was assessed with a barium upper gastrointestinal series or in some cases other imaging analysis to characterize the anatomy of the esophagus.
Time frame: 2 years
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Virginia Heartburn and Hernia Institute
Lorton, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States