ATHERO52, A Proof of Concept Device Design to Remove and Treat Atherosclerosis with a Non-Invasive Surgical Approach

Abstract

Atherosclerosis, associated with coronary artery disease (CAD) contributes to one of the largest reasons for deaths worldwide in 2017 (Center for Disease Control and Prevention [CDC], 2019a). Commercialized devices on the market focus primarily on the treatment of peripheral artery disease (PAD) rather than CAD (Fornell, D., 2020, January 3). Divulging into the knowledge of previous atherectomy devices RotaPRO (Boston Scientific), Pantheris (Avinger), TurboHawk (Medtronic) and Jetstream Atherectomy (Boston Scientific), SilverHawk (Medtronic), Diamond Back 360 Coronary Orbital Atherectomy System (Cardiovascular Systems) and CVX-300 Excimer Laser System (Spectranetics) each contribute in some way to the inspiration and design of ATHERO52. (Topfer LA & Spry C., 2018, April 1). The goal of this research facilitates creation of a medical device for the coronary artery atherectomy system that incorporates both new and former technologies to provide a minimally invasive approach and safe treatment for patients with CAD. ATHERO52 takes on a fresher approach in atherectomy systems with the use of optical coherence tomography (OCT) to better visualize the inside of the arteries during the procedure. Inspired by Pantheris (Avinger, 2020) ATHERO52 incorporates two OCT imaging sensors to provide a clear visual representation for the location of healthy tissue layers when navigating and performing plaque removal in the vessels. OCT reduces the potential proliferation of tissue along the vessel wall when extracting plaque. In addition, with much research ATHERO52 includes the use of directionality steering to eliminate the need of a guidewire housed within the device and promotes a greater level of safety and efficacy. Research uncovers guidewires on several devices such as the Diamond Back 360 Orbital Atherectomy System experiencing difficulties in placement and removal resulting in harm to the patient (U.S. FDA, 21, August 2018). Lastly, ATHERO52 addresses the necessity for a plaque removal component that is employed along the pathway to the target site with the use of a forward-facing cutter. The forward-facing cutter permits the operator to generate a clear path to the target site while also enabling easier extraction of the system when the procedure is complete. The design of this device eradicates harmful components found on previous systems, shortens procedure and recovery time while focusing on a prevalent disease that affects individuals worldwide.