Post-market, Prospective Evaluation of PHOTO-oxidized Bovine Pericardium in Vascular Surgery

Inclusion Criteria

• Patient is undergoing a vascular procedure which falls within the indications for use and requires the use of PhotoFix Decellularized Bovine Pericardium
• Patient's surgery is anticipated to occur within 60 days of consent
• Patient is ≥18 years old
• Patient is willing and able to comply with the protocol and follow up period
• Patient is willing and able to give written informed consent

Exclusion Criteria

• Patient's procedure is a revision of a prior arteriotomy or venotomy
• Patient's procedure requires multiple vascular patches in anatomically distinct regions or other prosthetics (e.g. stents)
• Patient has a medical history of abnormal coagulopathy, bleeding, or thromboembolic disease
• Patient has a medical history of severe immunodeficiency disease
• Patient has a medical history of cancer
• Patient has severe visceral disease in heart or active liver disease or icterus
• Patient has a history of cerebrovascular accident (completed stroke) within 3 months of planned surgery
• Patient has a history of atrial fibrillation and requires a patch for carotid endarterectomy repair
• Patient has an active or potential infection at the surgical site
• Patient has used or plans to use immunomodulatory drugs for ≥ 6 months
• Patient has a sensitivity to products of bovine origin
• Patient is currently enrolled in another study
• Patient has a life expectancy of less than 12 months
• Patient is pregnant or breastfeeding or planning on becoming pregnant or unwilling to use medically acceptable methods of birth control
• Patient's procedure is emergent