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 fund collaborative translation of this novel technique into patients. A first in human test of mitral cerclage annuloplasty was performed and reported by our laboratory alumnus and close collaborator in Pusan Korea. We are developing a refined system of devices for mitral cerclage annuloplasty, and are working closely with an industry contractor to test these devices on patients in the USA next year. We are analyzing the results of a first-in-human test performed by our laboratory alumnus and close collaborator in Pusan Korea. 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 are working with a large medical device manufacturer to further develop these devices for testing in patients in the USA, as soon as next year. 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 240 over 400 patients to date. We completed a prospective multicenter test of the safety and effectiveness of this technique on 100 patients, and showed it appears satisfactory even in centers with limited experience, and that the results may be better than surgical access for transcatheter aortic valve replacement through the chest. We have developed transcaval closure devices that are easier and potentially safer for less experienced operators to use on their patients. We are working closely with a contractor to test these new devices on patients in the USA next year. We are analyzing the results of a multicenter test that we conducted 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 a completely new approach to prevent a life-threatening complication of the transcatheter mitral valve implantation. In as many as a third of patients, the transcatheter mitral valve forces the natural mitral leaflet to block blood as it leaves the heart, a condition called left ventricular outflow tract obstruction. We developed a technique called LAMPOON to split the native anterior mitral leaflet and showed how it works in animals. It has been successfully applied in a small number of 7 patients so far. We have begun to test the technique in a prospective multicenter study in the USA. We recently developed a related technique to prevent a life-threatening complication of transcatheter aortic valve replacement. A small number of patients, especially after a surgical tissue aortic valve begins to fail, transcatheter aortic valve replacement is dangerous or impossible because the existing tissue leaflets can block off the coronary arteries. In a modification of the LAMPOON technique, we have developed and tested a new technique called BASILICA (Bioprosthetic Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction) in animals. The technique has been used on a compassionate basis to a small number of patients at two medical centers in the USA. We are preparing to study this technique more closely in a prospective clinical investigation.
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