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3D Holographic Guidance, Navigation, and Control (3D GNandC) for Endovascular Aortic Repair (EVAR)

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44HL139290-02
Agency Tracking Number: R44HL139290
Amount: $1,473,804.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NHLBI
Solicitation Number: PA18-573
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-09-01
Award End Date (Contract End Date): 2021-08-31
Small Business Information
Cleveland, OH 44106-2119
United States
DUNS: 080088507
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (216) 445-0830
Business Contact
Phone: (440) 533-1950
Research Institution

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 (Pandamp;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 Pandamp;O maneuvers as the delivery system approaches the aneurysmandapos;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.Project Narrative
This project provides new 3D holographic visualization with mini-GPS-like navigation to precisely thread a
stent-graft through arteries to an aortic aneurysm during minimally invasive surgery. Patient-specific 3D
visualization displayed directly on the patient instead of a 2D monitor will decrease the use of 2D x-ray
fluoroscopy while surgeons accurately anchor a stent-graft inside an aorta, resulting in fewer complications
after surgery and less x-ray radiation exposure to patients and surgical staff. Advantages of this aortic
procedure, as well as future vascular and cardiac procedures, will be fully realized, leading to improvements in
cost and quality of care for the healthcare system.

* Information listed above is at the time of submission. *

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