HIGH-SPEED DUAL ENERGY DIGITAL SUBTRACTION ANGIOGRAPHY

在美国，每年有超过2000个导管实验室进行超过100万次冠状动脉导管置入和同等数量的非冠状动脉导管置入。科学研究实验室（SRL）建议开发一种改进的数字技术，用于可视化对比度填充结构，该技术可应用于对比度成像目前使用的所有情况，比现有技术具有许多优势。该技术名为双能数字减影血管造影（DEDSA），使用一种专有的x射线源，依靠新型阳极涂层和x射线过滤器来增强对造影剂的敏感性，同时抑制组织和骨骼的特征。在之前的工作中，SRL证明了碘造影剂在校准的拟人模型以及切除的动物器官内的DEDSA成像。在这个程序中，我们将包括使用钆造影剂的能力。钆化合物在DEDSA成像中比碘具有许多优点，包括改善组织和骨骼的消除，降低患者剂量，目前广泛用作MRI造影剂。该计划的目标是开发和测试能够对动物受试者进行实时减影成像的临床DEDSA原型。第一阶段计划的重点是开发双光谱x射线源，这是DEDSA的基础。该项目是与贝斯以色列女祭司医院首席放射科医生Melvin Clouse博士合作进行的，他将协调该设备在第二和第三阶段的动物试验。建议的商业应用：SRL专有的DEDSA技术可以作为新导管实验室的一部分或作为现有设备的升级。冠状动脉造影在美国是一个价值50亿美元的产业。美国有超过2000个导管实验室，欧洲有大量市场，预计亚洲也有市场，对这项技术的潜在需求是巨大的。一旦证明，SRL将寻求与血管造影设备供应商的战略合作伙伴关系。

There are over 2000 catheterization laboratories in the U.S. performing over 1 million coronary catheterizations and an equivalent number of non- coronary catheterization procedures per year. Science Research Laboratory (SRL) proposes to develop an improved digital technique for visualizing contrast-filled structures that could be applied in all cases where contrast imaging is currently used with many advantages over current techniques. The technique, Dual-Energy Digital-Subtraction Angiography (DEDSA), uses a proprietary x-ray source that relies on novel anode coatings and x-ray filters to enhance the sensitivity to contrast agent while suppressing features due to tissue and bone. In previous work, SRL demonstrated DEDSA imaging of iodine contrast agent within calibrated anthropomorphic phantoms as well as within excised animal organs. In this program we will include the capability of using a gadolinium contrast agent as well. Gadolinium compounds offer many advantages over iodine for DEDSA imaging, including improved tissue and bone cancellation and lower patient dose, and are currently widely used as MRI contrast agents. The goal of this program is to develop and test a clinical DEDSA prototype capable of performing real-time subtracted imaging of animal subjects. The Phase I program is focused on the development of the dual-spectrum x-ray source that is the basis of DEDSA. This project is being carried out in collaboration with Dr. Melvin Clouse, Radiologist in Chief at Beth Israel Deaconess Hospital, who will coordinate testing of the device on animal subjects in Phase II and III. PROPOSED COMMERCIAL APPLICATIONS: The SRL proprietary DEDSA technology can be offered as part of a new catheterization laboratory or as an upgrade to existing equipment. Coronary procedures involving contrast imaging represent a $5B industry within the United States. With over 2000 catheterization laboratories in the United States, substantial markets in Europe, and expected Asian markets, the potential demand for this technology is substantial. Once demonstrated, SRL will seek a strategic partnership with a supplier of angiography equipment.