Grant: Project Grant

Conventional catheter-based minimally invasive cardiovascular interventions face two fundamental challenges: the first is associated with the catheter's limited steerability and support due to its long length, high flexibility, engagement with the anatomy, and its remote manipulation from outside the patient body; the second is associated with poor visualization as x-ray imaging fails to provide 3D anatomical visualization. These constraints hinder accurate and effective catheter navigation, ultimately contributing to long procedure times, high failure, and complication rates. To address this problem, we have developed a radically different steerable catheter. It consists of an expandable frame, which is initially constrained within an outer sheath until it is brought to the vicinity of the target anatomy. Then the frame is expanded and anchors to the anatomy of interest. Once expanded, the frame can be mechanically leveraged, and it allows for local manipulation and tracking of an internal catheter relative to this frame. This platform technology provides a passive and inexpensive solution that overcomes the intrinsic limitations of conventional devices. This solution offers localized manipulation and control, accurate tracking, and reliable navigation of the catheter relative to the anatomy of interest rather than a random trial and error approach that exists with remote manipulation of conventional devices. With the goal of commercializing this technology for an initial target application of peripheral endovascular revascularization, the proposed activities of this application entail finalizing design revisions of this technology and performing preclinical and clinical studies. The preclinical and clinical study results will be a major inflection point that will lead to further interest from end-users, private investors, and potential industrial partners to allow for the commercialization of the technology at a global scale.