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

PhotoFix is prepared from bovine pericardium, which is stabilized using a dye-mediated
photo-oxidation process and sterilized using aseptic processing techniques. The primary
endpoint for patients with carotid artery stenosis (CAS) undergoing carotid endarterectomies
(CEA) will be rate of ipsilateral central neurologic events; the primary endpoint for all
other vascular procedures will be primary patency. The secondary endpoints include all-cause
reoperation rate, device-related reoperation rate, explant rate, restenosis rate, secondary
patency (hemodialysis access repair (HAR) only) and survival. A goal of 100 patients will be
enrolled at approximately 10 sites. The enrollment period will span a minimum of 8 months
from Institutional Review Board (IRB) approval and site activation. Candidates for this study
are adults who require vascular repair or reconstruction surgery that necessitates the use of
a patch. Patients will be consented pre-operatively and enrolled patients will be followed
for approximately 6 months after PhotoFix surgery. Data will be collected at 5 time points:
baseline (pre-operatively), intra-operatively, 1 month post-operatively, 3 months
post-operatively, and 6 months post-operatively.

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