Development of a novel mitral valve repairment device with delivery system for the treatment of mitral valve regurgitation: an in-vitro safety assessment

Mitral valve prolapsed is a prevalent condition that leads to mitral regurgitation, resulting in the backflow of blood into the left atrium. This condition imposes an increased workload on the heart, potentially leading to the weakening of the heart muscle over time. In this research study, we have presented a concise depiction of a novel mitral valve repairing device designed specifically for the treatment of mitral valve regurgitation. The proposed implant incorporates various components, including a fastener, a slotted nut, multiple crowns and anchors which are interconnected in a predefined manner to enable circular expansion of the implant. The V-shaped structure of the crowns ensure the equal stress distribution during leaflet actuation & minimizing the risk of tissue wall damage. The circularly expandable nature of the implant allows for effective treatment of annular regurgitation of the mitral valve within the native annulus. In order to evaluate the safety and efficacy of the MVR device, in-vitro testing was conducted. This approach allowed the study to be ethically viable while ensuring relevance to human physiology, cost-effectiveness, a controlled experimental environment, risk identification and mitigation, and adherence to regulatory requirements. The preliminary findings obtained from this in vitro testing provided valuable insights into the safety profile of the mitral valve repairment device.