Towards virtual laboratory for optimal patient-specific cardiac resynchronization

描述(申请人提供)：心脏消融技术公司的目标是开发一种基于模拟的方法，并将其商业化，以非侵入性预测梗死相关室性心动过速患者导管消融的最佳目标。商业化的成功完成将导致室性心动过速消融临床过程中的重大范式转变，在临床过程之前，将通过MedicoSolv的方法对每个患者心脏的最佳消融目标进行准确预测。在这些预测的指导下，消融将以最小的病变大小迅速而准确地根除所有与梗塞相关的室性心动过速。这将导致治疗的有效性和耐受性的显著改善，以及术后并发症的减少。该项目的目的是将我们的基于模拟的消融指导作为一种商业级软件医疗设备，准备等待监管部门的批准。为了实现这一目标，MedicoSolv将在遵循全球监管机构要求的严格质量程序的同时开发该软件。在整个开发过程中，测试将确保所有证明该方法的初步结果将被最终的商业产品复制。

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.