Antimicrobial Hernia Repair Device

Feasibility Study of the Antimicrobial Hernia Repair Device for Repair of Ventral or Incisional Hernia

This prospective early feasibility clinical study will collect information regarding the safety and efficacy of the Cook® Antimicrobial Hernia Repair Device to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated and contaminated (i.e., Class II and Class III) surgical fields.

Inclusion Criteria:

• Patient with ventral or incisional hernia that is to be surgically corrected in a Class II and Class III surgical field.

Exclusion Criteria:

• Less than 21 years old
• Unwilling or unable to sign and date the informed consent
• Pregnant, breastfeeding, or planning to become pregnant prior to completing the study
• Unable or unwilling to comply with follow-up schedule
• Simultaneously participating in another investigational drug or device study.
• Medical condition or disorder that would limit life expectancy to less than the primary clinical study endpoint.