Paradigm Surgical LLC — Department of Health and Human Services STTR Phase I: 300

Description

Contact PD PIFischerJohn Dual Tack Mesh Fixation SystemCreation of a Mesh Fixation System for Hernia Treatment and PreventionIncisional herniaIHis a significant public health issue in the United StatesUSwith an estimatedcases per year and over $billion spent on hernia treatmentRecurrence rates for surgical IH repairs areand those who experience recurrence are susceptible to a vicious cycle of morbidity as each subsequent repair presents greater technical challengescostsand increased risk for recurrenceIn order to combat this growing epidemicit is critical to establish optimal treatment modalities for hernia AND to also identify opportunities for preventionThe mesh onlay procedure has been shown to effectively do bothas it reduces recurrence for hernia treatment and prevents hernia occurrence for high risk open fascial closures when no hernia is presentThe combined effect is fewer recurrent hernias and fewer incisional herniasDespite these established benefits and the acceptable riskthere is a lack of widespread adoption of the mesh onlay procedureSurgeon level barriers are a key impediment to adoption due to the added time for mesh onlay and its technical complexityAlthough various technologies have been developed in the attempt of decreasing the operative time and the technical difficulty of the proceduremany of these technologies are designed for laparoscopic use andtherefore have inherent design limitations for use in open surgeryWith open surgery still largely being considered the `gold standardandaposin hernia treatmentthere is a critical need for an innovative and enabling technology that directly addresses these limitationsThe Dual Tacker SystemTM offers a direct solution to the limitations of existing tacker devicesas it represents a uniquely innovative approach to mesh onlay for both hernia treatment and preventionThe Dual Tacker is the first device to allow for simultaneous tensioning and tacking of the meshIt is also the first device to utilize a dual firing mechanism that firestacks through the mesh and fascia withpull of the triggerAdditionallya largercustom designed tack improves the versatility and reliability relative to currently used tacks by providing higher fixation force with larger barbsThese innovationsalong with the ability to change the inter arm distance and permit fixation at multiple points and in various mesh sizesallows the user to rapidlyuniformlyand effectively tension and affix the mesh to reinforce the anterior abdominal fasciaall with one hand held systemWe propose a systematic approach to refinement and proof of concept for the Dual Tacker SystemSuccess of this Phase I proposal will be defined by creating a prototype of the system that can incorporate our proprietary tackis capable of rapid dual sided mesh fixation and pretensionand is capable of rapid inter arm width manipulation for adaptation across various mesh sizesSuccess of the prototype assessment phase will be defined by reduced time and number of hand movements relative to other fixation methodswhile achieving improved biomechanical strength of the repairThe proposed research objectives will promote more widespread use of the mesh onlay procedure and thereby aid in interrupting this vicious cycle of hernia Contact PD PIFischerJohn Dual Tack Mesh Fixation SystemCreation of a Mesh Fixation System for Hernia Treatment and PreventionIncisional herniaIHis a significant problem in the USThis problem can be addressed with the mesh onlay procedurewhich has been proven to effectively treat and prevent IHThis procedure however is not widely adopted due to several key technical limitations with the current state of the artThe Dual Tacker SystemTM offers a solution to those limitation by providing a novel approach to the problem and thereby increasing the efficiency and effectiveness of mesh onlay for BOTH treatment and prevention