PFI:AIR - TT: External Stents to prevent vein failure in dialysis grafts

Vanderbilt University, Nashville TN

Investigators

Abstract

This PFI: AIR Technology Translation project focuses on developing and commercializing a shape memory polymer external stent, VenoStent, to prevent vein failure in hemodialysis patients. Although hemodialysis is the primary lifeline for patients with end-stage kidney disease, vein failure necessitates expensive, rather ineffective interventional techniques and re-do operations. This puts the patient at an undue risk of infection, extensive hospitalizations, and death, with substantial, adverse ripple effects on the economy. This project will result in an optimized prototype of the VenoStent positioned for clinical translation. VenoStent has the unique capability to robustly encompass the complex, variable geometry of the graft-vein junction, where the majority of failures occur. It is also biocompatible, biodegradable, ductile, and tunable for optimal venous responses. In contrast to other competing technologies in development, these features enable sutureless, custom-fittable encompassing of the vein to reduce surgery times, risk of infection and wound reopening. These features should also impart reductions in hospitalizations, interventional techniques, re-do surgeries, and costs. This project addresses the following technology gaps as it translates from research discovery toward commercial application. First, the prototype must be optimized for its ability to encompass the venous anastomoses and promote a healthy vascular smooth muscle cell (VSMC) phenotype, as VSMCs play an integral role in the underlying neointimal formation responsible for vein failures. Sustained release of a therapeutic peptide, MK2i, from the external supports will also be evaluated in vitro for future commercialization adaptability incorporating a therapeutic. The precise geometry of the construct, pore size, and molar composition will be defined and then tested in an ex vivo model of the venous anastomosis. In addition, personnel involved in this project, namely a graduate student and post-doc, will receive extensive entrepreneurial and technology translational opportunities through participation in business courses, pitches, competitions, accelerator programs, and professional conferences.