Surefire Precision Infusion System Registry

Conventional transarterial chemoembolization with lipiodol/doxorubicin (cTACE) is known to
prolong survival compared to supportive therapy in certain patients with unresectable HCC,
including patients with unilateral portal vein invasion (PVI). The best results for cTACE
occur when the dose is delivered in a highly targeted manner into the tumor. Dense
accumulation of embolic spheres or lipiodol into the tumor as documented by computed
tomography (CT) has been shown to have improved outcomes. However, with standard endhole
catheters, achieving maximum delivery of embolic agents is significantly limited by the
development of stasis, non-target delivery and subsequent non-target injury. Thus, when this
procedure is performed with endhole catheters, there is significant variability in the
delivery of the agent that is entirely dependent on the flow pattern of the target tumor.
Therefore, current techniques result in various degrees of embolization with variability in
dosages and angiographic endpoints.

DEB-TACE is a relatively new modality associated with favorable systemic doxorubicin
exposure/toxicity and liver-specific toxicity compared to cTACE. It is currently utilized
for: (1) patients who have unresectable HCC; (2) patients who meet the Milan Criteria and are
currently on liver transplantation lists; and (3) downstaging patients into Milan Criteria
for possible liver transplantation.

Inclusion Criteria:

- Patients who have undergone or will undergo DEB-TACE for HCC delivered by the
Surefire® Precision Infusion System

- Patients aged 18 years or older

- Diagnosis of HCC

- Has a discrete hepatic artery(s) feeding the vessel with diameter(s) of the vessels ≥
1.5 mm

Exclusion Criteria:

- Contraindications for doxorubicin administration

- Vessels providing flow to the tumor that are < 1.5 mm in diameter(s)

- Patients who are unable to provide informed consent