Abbott Initiates New Intravascular Lithotripsy Clinical Trial to Improve Outcomes in Patients with Coronary Artery Disease

Core Insights - The U.S. FDA has approved Abbott's investigational device exemption for its Coronary Intravascular Lithotripsy (IVL) System to treat severe calcification in coronary arteries prior to stenting [1] - The TECTONIC Coronary Artery Disease (CAD) clinical trial will enroll up to 335 participants across 47 sites in the U.S. [1] Industry Context - Coronary Artery Disease (CAD) is the most prevalent heart disease in the U.S., affecting over 20 million adults and being the leading cause of death [2][8] - CAD is characterized by plaque buildup in arteries, which obstructs blood flow and oxygen supply to the heart, necessitating vessel interventions [2] Company Overview - Abbott's Coronary IVL System utilizes high-energy sound pressure waves to fracture calcium blockages in arteries, potentially improving stent placement and vessel expansion [3][4] - The company aims to enhance treatment options for patients with severe calcification, which complicates standard interventions like angioplasty or stenting [4] - Abbott's existing vascular portfolio includes optical coherence tomography (OCT) technology for assessing coronary arteries and detecting calcium buildup [4][5] - The investigational Coronary IVL System is part of Abbott's broader strategy to advance calcium modification technology and improve treatment efficacy for coronary artery disease [5]