Research Project
10001634
Project Summary/Abstract This SBIR Phase II project will advance the commercialization of our 3D guidance, navigation, and control (3D- GNC) system to improve stent-graft (SG) deployment during endovascular aortic aneurysm repair (EVAR) by overcoming limitations of 2D x-ray fluoroscopy (?fluoro?). 3D-GNC will increase safety, effectiveness, and efficiency as a result of better visualization, particularly when deploying SGs within hostile aortic anatomy, with challenges such as short and/or angled landing zones. True 3D (360°), radiation-free GNC that is not limited by a 2D display will decrease radiation to patients and OR staff, reduce procedure time, and enable accurate SG positioning leading to fewer postoperative complications or need for re-intervention. Converting this innovation to a product will expand the patient population eligible for EVAR, particularly those with highly unfavorable aortic anatomy, as the demand and utilization of the minimally-invasive approach continues to rise. In Phase I, a 3D-GNC research prototype was developed and integrated with our Intra-Operative Positioning System (IOPS). The Guidance subsystem digitally augments the patient-specific aortic model to the surgical field using a modern, self-contained augmented/mixed reality head mounted display. Navigation accurately tracks in real-time the 3D position and orientation (P&O) of a sensor-equipped wire (IOPS-SG1 Wire) for projecting a SG hologram in spatial registration with the aorta hologram. Our holographic Control panel suggests P&O maneuvers as the delivery system approaches the aneurysm's proximal neck landing zone. Phase I results met all acceptance criteria for Specific Aims in terms of 1) usability in bench testing by a focus group of 10 surgeons, 2) accuracy for SG delivery system positioning in six 3D-printed aortic models with complex anatomy, and 3) benefits of 3D-GNC in our preclinical protocol relative to fluoro: radiation dose and contrast dose (100% decrease), procedure time (56.4% decrease), and orientation accuracy (41.5% increase). In Phase II, we will develop, verify and validate the 3D-GNC system based on Phase I outcomes, on-going user feedback, and our quality management system (QMS). We will evaluate usability at 3 leading aortic medical centers (Aim 1) and verify accuracy on the bench by deploying SGs from at least 2 manufacturers in 3D-printed models using designed controlled system components (Aim 2). After IDE and IRB clearance, we will conduct a first-in-human study in Aim 3 to demonstrate that use of 3D-GNC as an adjunct to and confirmed by fluoro is safe and effective and can lower radiation dose, while obtaining feedback for design finalization. All development will be in compliance with our QMS, toward preparation for FDA premarket clearance (Aim 4). Overcoming limitations of fluoro and improving SG placement will pave the way to realizing the full clinical and economic benefits of EVAR over highly invasive open surgical repair. Commercialization of our technology will have implications beyond aneurysmal disease to include many emerging vascular and cardiac procedures to benefit a broader population of patients, caregivers, and enable delivery of better quality healthcare globally.
