Journal of Vascular and Endovascular Therapy

Preclinical Investigation of a 2nd Generation DermaPort^™ Ported Vascular Access System (PVAS)

Introduction: The DermaPort™ Ported Vascular Access System (PVAS) was developed to improve central line access and reduce infections in hemodialysis while permitting catheter repositioning or replacement without disruption of the ingrown port. The PVAS port is comprised of a percutaneous titanium conduit with a subcutaneous titanium mesh ingrowth cuff and a disengageable silicone brake. Feedback from the clinical trial revealed that replacement of the peel away sheath (Gen1) with a dilating housing (Gen2) would be an improvement. Objective: Design and validate in vivo a Gen2 design that replaces the user-dependent peel away sheath. Methods: Three candidate housing designs and then three potential mesh cuff positions for the optimized Gen2 dilating housing without a sheath were screened in an acute porcine insertion model. These designs were compared to Gen1 with a sheath and a polyester-cuffed catheter. Next, the selected design and three potential mesh cuff positions were further tested in chronic 6-week and 4-week chronic rabbit studies, respectively. Both chronic studies histologically characterized mesh ingrowth and marsupialization in comparison to Gen1 and polyester-cuffed catheter controls. Results: Insertion of the Gen2 housing with a 10° dilating distal end was determined to be the most similar to Gen1 in the porcine model. The 4 and 6-week rabbit implant study showed a trend towards greater down growth for the deeper mesh designs and no observation of marsupialization. There were no significant differences in connective tissue ingrowth between the two PVAS housing designs or the mesh positions in the six week study, which was more mature and less inflammatory than in polyester-cuffed controls. Conclusions: These data provide support for the further development of the Gen2 PVAS in response to clinical feedback on the Gen1 design.t.

Author(s):

Abram D Janis, Thomas J Lobl and Buzz Moran

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