Trial Parameters
Brief Summary
A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / Hiatal Hernia Repair). The primary objective of this study is to collect GORE® ENFORM Biomaterial product commercial-use data on device functional performance and short-term patient experience.
Eligibility Criteria
Pre-procedure Inclusion Criteria: The subject is / has: 1. At least 18 years old at the time of informed consent. Minimum age required by state regulations (as applicable). 2. An expected scored Class I (Clean) surgical wound using CDC Surgical Wound Classification system. 3. A planned implant with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture line reinforcement. 4. An expected scored Grade 1 or Grade 2 using the Ventral Hernia Working Group Grading system. 5. Willing to provide informed consent and comply with follow-up requirements. Pre-procedure Exclusion Criteria: The subject is / has: 1. Treated in another drug or medical device study within 1 year of study enrollment. 2. Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects. 3. Hernia repair expected to be performed as part of a bridged procedure (i.e., expected inability to perform primary closure of fascia or crura, patients requiring permanent support fro