Paradigm Surgical Phase II-Development and Validation of SafeClose Roller Mesh Augmentation System for Hernia Treatment and Prevention

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Paradigm Surgical Phase II–Development and Validation of SafeCloseTM Roller Mesh Augmentation System for Hernia Prevention Each year an estimated 153,000 cases of incisional hernia (IH) repairs are performed in the United States and over $7 billion is spent on hernia treatment. Mesh onlay, which involves fixating mesh onto the closed abdominal wall to reinforce the incision, is a procedure that was developed in the attempt to both address hernia recurrence (hernia treatment) and as a means of prophylaxis (hernia prevention). This procedure is a safe and highly effective technique that reduces the risk of IH by up to 34%. Mesh onlay is traditionally performed by hand- sewing mesh onto the abdominal wall, which requires additional operative time and is technically difficult – both of which are key barriers to market entry. Current mesh fixation technologies are inefficient due to their: (1.) inability to tension mesh, (2.) requiring external cutting of mesh, and (3.) lack of mesh uniformity, which compromises biomechanical strength and effectiveness. Despite the established benefits and the acceptable risk, there is a lack of widespread adoption of the onlay procedure. Surgeon-level barriers are a key impediment to adoption due to the added time and difficulty of mesh onlay. These barriers highlight an unmet clinical need for an effective technology that decreases time and circumvents the technical challenges of mesh onlay. The SafeCloseTM Roller system addresses these needs by providing a mesh application system that rapidly and uniformly applies tensioned mesh onto anterior abdominal fascia for BOTH hernia treatment and hernia prevention. It is comprised of a handheld applicator that houses a strip of tensioned mesh and utilizes a proprietarily developed spring-loaded tack fixation mechanism to fixate the mesh. The device mitigates the technical challenge of traditional mesh onlay by obviating time-consuming hand-sewing of the mesh and by standardizing the often variable mesh tensioning and affixation. The SafeClose is the first-ever device to provide a mesh fixation mechanism that couples the mesh to the affixation system, also allowing for individualized mesh sizing. This allows the user to rapidly apply and cut the pre-tensioned mesh to reinforce the fascia. In this Phase II proposal, we propose a systematic approach to advance the design of the SafeClose system to reach the pivotal point of design freeze and subsequently validate the device’s performance in cadaveric porcine abdominal wall, in-vivo porcine abdominal wall, and in human cadavers. The proposed aims for this Phase II project will play a critical role in producing important, clinically relevant data that will help propel the device to FDA clearance and successful commercialization in the near future. Success of this project will be defined by significantly reduced time and number of hand movements relative to other fixation methods in the human cadaver study, while also achieving equivalent or improved biomechanical strength of the repair in both the cadaveric and in-vivo porcine models as compared to the standard-of-care. These proposed research objectives will help bring our device closer to commercialization, which would ultimately help promote more widespread use of the mesh onlay procedure and thereby aid in interrupting the vicious hernia cycle.