Development and Validation of SafeClose Mesh Augmentation System for Hernia Prevention

Paradigm Surgical, Llc, Philadelphia PA

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Linked publications & trials

Abstract

Incisional hernia (IH) can be prevented using prophylactic mesh placement (PMP), which involved placement of mesh to reinforce an abdominal fascia closure before herniation occurs at the index of surgery. PMP reduced the absolute risk of IH, with an acceptable complication profile. Open abdominal surgery techniques remain commonplace and contribute to the estimated 153,000 cases of IH performed in the United States (US) and the associated $3 billion spent on hernia treatment. To reduce these hernias, more widespread adoption of PMP is needed, yet barriers exist to adopting PMP in practice. Surgeon-level barriers are a key impediment due to the added time for PMP (20-30 minutes). A rapid mesh application system can reduce this time and increase utilization of PMP. Further, the reliability and technical challenges inherent to PMP pose significant challenges. These barriers highlight an unmet clinical need for an effective, well-engineered, intra- operative technology to decrease the time and circumvent the technical challenges of applying mesh to the abdominal wall fascia for hernia prevention. The SafeClose Mesh Augmentation System is a medical grade, hand-held, mesh affixing system. The system increases the speed of mesh affixation and circumvents technical intra-operative challenges by integrating several key steps of the PMP process, including positioning, tensioning, and affixation into one system. The system includes sterilized mesh with pre-integrated fastener anchors along with a customized applicator that houses the mesh-fastener system inside. By pulling the applicator along the length of the incision, the mesh rolls out of the applicator and is simultaneously affixed by the fasteners. In one continuous motion, the entire incision can be reinforced. When the surgeon reaches the bottom of the incision, he/she can cut the mesh off using the built-in cutting mechanism. This newly updated design satisfies important end-user needs by providing an ergonomic yet robust application mechanism, while at the same time allowing the device to accommodate for different incision lengths and sizes giving the user full ability to control the length of mesh that is used. We propose a feasible, systematic, and step-wise approach to refinement and proof-of-concept for the SafeClose System. Success of this Phase I proposal will be defined by creation of a refined applicator whose core functionality includes a built-in cutting mechanism to reliably and safely cut the mesh after the surgeon has completed the procedure AND demonstration that the SafeClose significantly reduces the time relative to a hand- sewn technique (Aim 2 Experiment 1) while achieving equivalent or improved biomechanical strength of the repair (Aim 2 Experiment 2). The proposed research objectives will advance hernia care and begin a shift towards more preventative risk reductive interventions in abdominal surgery.