Evaluation of the Surfacer System Approach to Central Venous Access
Evaluation of the Surfacer System Approach to Central Venous Access
Pre-market Investigational device exemption study evaluating the safety and efficacy of the
 Surfacer System to facilitate stable upper body central venous access suitable for any
 conventional catheter.
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