DUCTUS ARTERIOSUS STENT TO IMPROVE CONGENITAL HEART DEFECT MORTALITY

摘要 儿科心血管内科医生（外科医生和 干预主义者）长期以来一直被忽视，迫使他们使用为成人设计的设备 和不同的条件来治疗有特殊解剖学考虑的患病婴儿。一 这种情况是在持续开放的动脉导管，一个天然的管道，存在于所有 新生儿，但出生后不久关闭。在某些先天性心脏病中， 新生儿无需手术干预即可存活。没有导管 在美国市售的动脉支架。儿科介入心脏病专家目前 重新使用成人冠状动脉导管支架，全因导管再介入率为47%。 另一种选择是对新生儿进行手术，放置分流器，其发病风险为7.2%， 在美国，死亡风险为13.1%。Starlight Cardiovascular建议创建和商业化 第一个FDA批准的动脉导管支架，专门设计用于解决 治疗医生面临的挑战，包括大小合适的输送系统，端到端 导管覆盖、通过迂曲导管解剖结构的导航和展开， 避免支架突出到主动脉和肺动脉中。设计了一种支架， 专门为此目的进行的测试有可能减少再干预，发病率， 对于导管依赖性循环的婴儿来说，这可能会导致死亡。第一阶段项目涉及 开发测试夹具、支架原型制作和测试以及临床前动物研究。由于 导管解剖结构的可变性，将从3D开发至少6个台式解剖模型 患者特定解剖结构的计算模型。星光的支架和输送系统将 使用解剖结构进行多次设计、构建和台架测试， 用于优化支架设计的输送能力、放置准确性和径向力的模型 专为具有挑战性的导管解剖学而设计。选择最终支架和输送系统设计， 最有前途的支架设计将急性植入新生羔羊，以评估其 体内性能。第一阶段项目将最终选出最好的导管 动脉支架和输送系统设计将在第II阶段接受设计确认试验， 准备FDA批准。

ABSTRACT The technical challenges faced by pediatric cardiovascular physicians (surgeons and interventionalists alike) have long been ignored, forcing them to use devices designed for adults and different conditions to treat ailing babies with very specific anatomical considerations. One such case is in the sustained opening of the ductus arteriosus, a natural conduit that exists in all newborns but closes shortly after birth. In certain congenital heart defects, it is crucial to maintain ductus patency for the newborn to survive without surgical intervention. There is no ductus arteriosus stent commercially available in the US. Pediatric interventional cardiologists currently repurpose adult coronary artery stents for the ductus, and all-cause ductus reintervention is 47%. The alternative is surgery on a neonate to place a shunt that carries a 7.2% risk of morbidity and 13.1% risk of mortality in the US. Starlight Cardiovascular proposes creating and commercializing the first FDA-approved ductus arteriosus stent that is specifically designed to address the challenges facing treating physicians, including a right-sized delivery system, end-to-end coverage of the ductus, navigation and deployment through tortuous ductus anatomy, and precise placement to avoid stent protrusion into the aorta and pulmonary arteries. A stent designed and tested specifically for this purpose has the potential to decrease reinterventions, morbidity, and potentially mortality for babies with ductal-dependent circulation. This Phase I project involves developing test fixtures, stent prototyping and testing, and a preclinical animal study. Due to the variability of ductus anatomy, at least six benchtop anatomical models will be developed from 3D computational models of patient-specific anatomy. Starlight's stent and delivery systems will then undergo numerous iterations of designing, building and benchtop testing using the anatomical models to optimize the stent designs for deliverability, placement accuracy and radial force tailored to the challenging ductus anatomy. To select the final stent and delivery system design, the most promising stent designs will be implanted acutely in neonatal lambs to evaluate their performance in vivo. This Phase I project will result in the ultimate selection of the best ductus arteriosus stent and delivery system design to undergo design validation testing in Phase II in preparation for FDA approval.