MRI catheter design and fabrication

在过去的一年中，我们继续致力于开发磁共振成像（MRI）兼容和可视设备，以执行计划在MRI下执行的腔内介入手术。 我们已接近完成一个人用级MRI导丝，可提供头端和轴的可见性，并在手术过程中提供安全保证。 我们制定了严格的良好实验室规范动物试验计划。 我们已经准备了一份监管提交文件，以便在明年进行首次人体测试。 我们继续开展介入性MRI器械的射频致热安全性测试。我们目前正在开发一种新的通用方案，以测试有源血管内器械在真实的时间MRI程序中的加热安全性 我们继续开发导管和植入物的新原型，以治疗瓣膜和先天性心脏病。 我们已经发明了几种新器械，包括基于导管的三尖瓣修复术、腔静脉-主动脉通路和大鞘管通路。

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.