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The Surfacer Inside-Out Access Catheter System is intended to obtain central venous access to facilitate catheter insertion into the central venous system for patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods.

The Surfacer Inside-Out Access Catheter System (Figure 1) is used to gain central venous access by directing a needle from inside the vein to skin, as opposed to the traditional approach of inserting a needle inwards. The Surfacer Device is percutaneously introduced into the right femoral vein. It is advanced up the inferior vena cava, via the superior vena cava (SVC), to the location of the occlusion. When the occlusion has been visualized under fluoroscopy, a needle wire is oriented to advance through or to cross the occlusion and to exit to a pre-determined external target. A new central venous catheter is then back-loaded into a peel-able introducer sheath and positioned below the occlusion for central venous access. The Surfacer Inside-Out Access Catheter System is comprised of four components: A Workstation Sheath for percutaneous access via the femoral vein; a Surfacer Device, comprising (b)(4). | Needle Wire and Needle Guide, which is advanced to the supraclavicular al space; an Exit Target, which provides fluoroscopic guidance to mark the exit point; and a | 10(4) (D) (4) Peel-able Introducer Sheath, which is introduced over the Needle Wire to access the central venous system. Once the access is obtained and a catheter is in place, the Surfacer System is removed. Please refer to the Instructions for Use for additional details.