MRI catheter design and fabrication

在过去的一年里，我们继续开发与磁共振成像(MRI)兼容的可视设备，以执行计划在MRI下执行的腔内介入程序。 我们几乎完成了一种人体级别的MRI导丝，它可以提供尖端和竖直的可见性，并提供手术期间的安全保证。我们已经制定了一套严格的良好的实验室实践动物测试计划。我们已经准备了一份监管意见书，允许在来年进行第一次人体试验。 我们继续致力于介入性核磁共振设备的射频加热安全测试。我们目前致力于开发一种新的通用方案，以测试实时MRI过程中主动血管内设备的加热安全性 我们继续开发用于治疗瓣膜和先天性心脏病的导管和植入物的新原型。我们已经发明了几种新的装置，包括基于导管的三尖瓣修补术、腔静脉-主动脉通路和大鞘通路。

During the past year we have continued our work developing magnetic resonance imaging (MRI) compatible and visible devices to perform endoluminal interventional procedures that are planned to perform under MRI. We have nearly completed a human-grade MRI guidewire that provides both tip and shaft visibility and provides assurance of safety during operation. We have developed a rigorous Good Laboratory Practice animal testing program. We have prepared a regulatory submission to allow first-in-human testing in the upcoming year. We continue to work on radio frequency heating safety tests of interventional MRI devices. We currently work on to develop a new general protocols to test heating safety of active intravascular devices during real time MRI procedures We continue to develop novel prototypes of catheters and implants to treat valvular and congenital heart disease. We have invented several new devices, including for catheter-based tricuspid valve repair, caval-aortic access, and large sheath access.