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

Paradigm Surgical II期-用于疝预防的SafeCloseTM滚动补片增强系统的开发和确认 美国每年估计有153，000例切口疝（IH）修补术 超过70亿美元用于疝气治疗。补片贴附，包括将补片固定在闭合的 腹壁加强切口，是一种试图解决疝 复发（疝治疗）和作为预防手段（疝预防）。这是一个安全的过程， 这是一种非常有效的技术，可将IH的风险降低高达34%。补片贴附传统上是手工进行的- 将补片缝合到腹壁上，这需要额外的手术时间，技术上也很困难- 这是进入市场的主要障碍。目前的网片固定技术由于其以下原因而效率低下：（1.） 无法张紧补片，（2.）需要网的外部切割，以及（3.）缺乏网格均匀性，这 会损害生物力学强度和有效性。尽管有既定的好处和可接受的 风险，缺乏广泛采用的onlay程序。外科医生级别的障碍是一个关键障碍 由于补片高嵌体增加了时间和难度，这些障碍突出了未满足的临床需求 一种有效的技术，减少时间和规避技术挑战的网状贴。 SafeCloseTM滚筒系统通过提供一种网片应用系统来满足这些需求，该系统可快速 并将张紧的补片均匀地应用于腹前筋膜上，用于疝治疗和疝 预防它由一个手持施用器组成，该施用器容纳一条张紧的网状物， 专有开发的弹簧加载大头钉固定机构来固定网。该器械缓解了 传统的网状物高嵌体的技术挑战在于避免了耗时的手工缝合网状物， 使经常变化的网张紧和固定标准化。SafeClose是有史以来第一个提供 将补片连接到固定系统的补片固定机构，也允许个性化补片 尺寸。这允许用户快速应用和切割预张紧的网片以加强筋膜。 在第二阶段的提案中，我们提出了一种系统化的方法来推进SafeClose的设计。 系统达到设计冻结的关键点，随后验证设备的性能， 尸体猪腹壁、体内猪腹壁和人尸体。拟议目标 对于这个第二阶段的项目将发挥关键作用，产生重要的，临床相关的数据，将有助于推动 该设备获得FDA批准并在不久的将来成功商业化。该项目的成功将是 定义为相对于其他固定方法， 人尸体研究，同时在两种情况下也实现了等同或改善的修复生物力学强度 尸体和体内猪模型与标准治疗相比。这些研究建议 目标将有助于使我们的设备更接近商业化，这将最终有助于促进更多的 广泛使用补片覆盖手术，从而有助于中断恶性疝循环。

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.