Towards virtual laboratory for optimal patient-specific cardiac resynchronization

描述（由申请人提供）：EASSOLV Ablation Technologies，Inc.旨在开发并商业化一种基于模拟的方法，用于无创预测梗死相关室性心动过速患者导管消融的最佳靶点。商业化的成功完成将导致室性心动过速消融临床手术的重大范式转变，其中在临床手术之前，将通过SolvesSolv的方法准确预测每个患者心脏中的最佳消融靶点。在这些预测的指导下，消融术的实施将是快速和精确的，以最小的损伤尺寸根除所有梗死相关的室性心动过速。这将导致治疗效果和耐受性的显著改善，以及术后并发症的减少。本项目的目的是将我们的基于模拟的消融指南作为商业级软件医疗器械实施，以备监管部门批准。为了实现这一目标，Solv将在遵循全球监管机构要求的严格质量程序的同时开发软件。在整个开发过程中，测试将确保证明该方法的所有初步结果将被最终商业产品复制。

DESCRIPTION (provided by applicant): CardioSolv Ablation Technologies, Inc. aims to develop and commercialize a simulation-based approach for non-invasive prediction of the optimal targets of catheter ablation in patients with infarct-related ventricular tachycardia. Successful completion of the commercialization will result in a major paradigm shift in the clinical procedure of ventricular tachycardia ablation, where accurate prediction of the optimal targets of ablation in each patient heart will be carried out by CardioSolv's methodology prior to the clinical procedure. Guided by these predictions, delivery of ablation will be swift and precise eradicating all infarct-related ventricular tachycardias with minimum lesion sizes. This will resul in a dramatic improvement in the efficacy of and tolerance for the therapy, as well as in reduction of post-procedure complications. The aim of this project is to implement our simulation-based ablation guidance as a commercial-grade software medical device ready for regulatory approval. To achieve this aim, CardioSolv will develop the software while following the strict quality procedures required by global regulatory bodies. Throughout development, testing will ensure that all preliminary results proving the methodology will be replicated by the final commercial product.