Evaluation of the Surfacer System Approach to Central Venous Access

This prospective, single arm, multi-center study is to demonstrate the safety and efficacy of
the Surfacer System. Safety will be evaluated based on the overall rate of acute
complications using the study device as compared to historical rates of device/procedure
related safety events using conventional central venous access methods. Efficacy will be
evaluated by the rate of transient successful central venous accesses created by the study
device. A total of 30 patients are planned to be enrolled, with 10 patients initially
following review of safety data. Duration expected to be through 7 days. A minimum of 3 sites
will participate in the study in the United States.

Inclusion Criteria:

- referred for placement of central venous access catheter

- have limited or diminishing upper body venous access

- have pathology impeding standard access methods

- willing to give written informed consent

Exclusion Criteria:

- occlusion of the right femoral vein

- occlusion of the iliac vein

- occlusion of the inferior vena cava

- contraindicated by physician

- acute thrombosis within any vessel planned to be crossed by the Surfacer *tortuous
anatomy which precludes a straight line from femoral vein to subclavian

- diagnosed with active pericarditis

- diagnosed with active endocarditis

- suspected pericardial effusion

- known or suspected aneurysm or ectasia of ascending aorta

- innominate artery or subclavian artery

- pregnant or of childbearing potential not taking adequate contraceptive measures or
nursing during study