Development of a Pediatric pVAD

儿科 pVAD 的开发

• 批准号: 7128196
• 负责人: ROBERT G SVITEK
• 金额: $ 44.11万
• 依托单位: CARDIACASSIST, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-07-01 至 2009-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7128196
• 关键词: auxiliary heart prosthesis; bioengineering /biomedical engineering; biomedical equipment development; biomedical equipment safety; catheterization; circulatory assist; clinical biomedical equipment; evaluation /testing; hemodynamics; medically underserved population; pediatrics; swine

DESCRIPTION (provided by applicant): Remarkable progress has been made over the last decade on ventricular assist devices for adult heart failure patients. Thousands of patients' lives have been saved each year. Unfortunately, similar devices are not yet available in the US for pediatric heart patients. Development of such devices has been impeded by the fact that the pediatric market size is too small to attract interest from medical device companies. This Phase II study is a part of a National Institutes of Health effort of encouraging industry to develop such devices for an underserved but high-benefit population - pediatric heart patients. The goal of this project is to further develop a pediatric percutaneous ventricular assist device (pVAD) based on the existing adult TandemHeart(tm) pVAD System developed and currently marketed by our company, CardiacAssist, Inc. In the Phase I study, feasibility of such a device for pediatric application was successfully demonstrated on the bench top. Phase II study will focus on development of complete clinical prototypes and animal testing. Specifically, a spectrum of different sized cannulae will be developed to serve pediatric patients of all ages, from neonates (> 2 kg) to young adults. State of the art computational fluid dynamic and fluid visualization techniques will be used to design a safer and more effective blood pump for this pediatric application to reduce the levels of hemolysis. Safety and functionality of the developed system will be demonstrated in animal models. Upon successful completion of Phase II, CardiacAssist will undertake the final design and commercialization phase to introduce this device into the market. The proposed pediatric pVAD system is the only one in the field that can be placed percutaneously and serve pediatric patients of all sizes. Because it is inserted percutaneously, cardiac assistance can be provided quickly and less invasively, minimizing potential complications and promoting quicker patient recovery. Successful commercialization of this device will bring a unique tool to pediatric cardiologists and surgeons for their use in saving children's lives.

描述（由申请人提供）： 过去十年来，成人心力衰竭患者的心室辅助装置取得了显着进展。每年有数千名患者的生命被挽救。不幸的是，美国还没有为儿科心脏病患者提供类似的设备。由于儿科市场规模太小，无法吸引医疗器械公司的兴趣，此类设备的开发受到阻碍。这项二期研究是美国国立卫生研究院鼓励工业界为服务不足但受益高的人群（小儿心脏病患者）开发此类设备的一部分。该项目的目标是在我们公司 CardiacAssist, Inc. 开发并目前销售的现有成人 TandemHeart(tm) pVAD 系统的基础上，进一步开发儿科经皮心室辅助装置 (pVAD)。在第一阶段研究中，该装置的可行性一种用于儿科应用的设备已在实验台上成功演示。二期研究将重点开发完整的临床原型和动物测试。具体来说，将开发一系列不同尺寸的插管，以服务于从新生儿（> 2 kg）到年轻人的所有年龄段的儿科患者。最先进的计算流体动力学和流体可视化技术将用于为儿科应用设计更安全、更有效的血泵，以降低溶血水平。所开发系统的安全性和功能性将在动物模型中得到证明。第二阶段成功完成后，CardiacAssist 将进行最终设计和商业化阶段，将该设备推向市场。 拟议的儿科 pVAD 系统是该领域唯一一个可以经皮放置并为各种体型的儿科患者提供服务的系统。由于它是经皮插入的，因此可以快速且侵入性较小地提供心脏辅助，从而最大限度地减少潜在的并发症并促进患者更快康复。该设备的成功商业化将为儿科心脏病专家和外科医生带来一种独特的工具，用于拯救儿童的生命。

项目成果

Trans-hepatic cannulation: a novel approach for placement of a pediatric percutaneous ventricular assist device.

经肝插管：一种放置儿科经皮心室辅助装置的新方法。

• DOI: 10.1097/01.mat.0000235486.37158.02
• 发表时间: 2006
• 期刊: ASAIO journal (American Society for Artificial Internal Organs : 1992)
• 作者: Gossett,JeffreyG;Wang,DavidHJ;Smith,DouglasE;Devaney,EricJ;Lloyd,ThomasR
• 通讯作者: Lloyd,ThomasR

Left ventricular assist via percutaneous transhepatic transseptal cannulation in swine.

通过猪经皮肝穿刺间隔插管辅助左心室。

• DOI: 10.1002/ccd.21934
• 发表时间: 2009
• 期刊: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
• 作者: Lim,DScott;Cortese,CoryJ;Loree,AmberN;Dean,DavidA;Svitek,RobertG
• 通讯作者: Svitek,RobertG