We are continuing development of transcatheter mitral cerclage annuloplasty, a novel technique which establishes circumferential tension around the mitral valve annulus by exploiting both natural (coronary venous) and un-natural (intramyocardial septal) trajectories. We have established proof-of-principal in a porcine model of ischemic cardiomyopathy that cerclage annuloplasty reduces secondary (functional) mitral valve regurgitation. While we refine devices, we are working to issue new contracts to small businesses to to fund collaborative translation of this novel technique into patients. We helped to test this technique in patients with our laboratory alumnus and close collaborator in Pusan Korea, in a first-in-human test of the approach. We have conceived a wholly new approach to treat tricuspid valve regurgitation called transauricular intrapericardial tricuspid annuloplasty (TRAIPTA). We have demonstrated the success of TRAIPTA to reduce functional tricuspid regurgitation in a new animal model. We recently entered into a Collaborative Research and Development Agreement with a large catheter company to develop this technique for testing in patients. Work continues apace. We have developed a new technique to introduce large implants into the aorta for transcatheter aortic valve replacement and related procedures, by crossing from the inferior vena cava into the abdominal aorta. This challenges the long-held paradigm that the aortic wall must remain inviolate during non-surgical procedures. The technique has proven lifesaving in over three dozen patients. We are sponsoring a multicenter evaluation of the technique while we develop purpose-built devices to close the access port. We have been educating physicians and their teams in this technique on three continents, where it has been applied successfully in 135 patients to date. We are sponsoring a multicenter test of the safety and efficacy of this technique throughout the USA. In addition to the broader application of transcaval access for transcatheter aortic valve replacement in patients, we have helped collaborators apply this technique for transcaval thoracic aortic endovascular aneurysm repair in patients. We have developed and tested an innovative approach to access the heart through the chest wall without surgery, in two different large animal species and in human cadavers.
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