Despite dramatic advances in the battle against cardiovascular disease, sealing of the femoral arteriotomy following percutaneous, transcatheter procedures remains a major challenge In the United States alone, over 48 million of these procedures are performed annually Manual compression is the most widely used method for achieving arteriotomy hemostasis However, compression is very time consuming and requires significant hospital resources Moreover, patients report that the most painful aspects of their catheterization experience are the manual compression of their catheterization site and having to lie immobile for hours so as not to disrupt healing of their arteriotomy A number of commercial devices to seal catheter wounds have been developed and are being marketed, however, these devices have drawbacks--they are invasive, expensive, difficult to use and leave behind foreign material In our Phase I effort, we demonstrated that high intensity focused ultrasound (HIFU) can successfully be used to noninvasively seal arteriotomies in large laboratory animals and, subsequently, in humans subjects In this Phase II application, we propose to (1) develop a clinical-level prototype device that uses ultrasound imaging and HIFU to facilitate noninvasive femoral arteriotomy sealing, (2) conduct key preclinical studies in an animal model, and (3) design and develop a phase I clinical trial protocol In Phase III, human clinical trials would be performed and product commercialization would commence.
