March 24, 2025- Abbott announced that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) for its Coronary Intravascular Lithotripsy (IVL) System to evaluate the treatment of severe calcification in coronary arteries prior to stenting. The TECTONIC Coronary Artery Disease (CAD) Intravascular Lithotripsy (IVL) clinical trial will enroll up to 335 people in 47 sites in the U.S.
Coronary Artery Disease (CAD) is the most common heart disease in the U.S., with more than 20 million adults impacted by the condition. CAD also remains the single most frequent cause of death in America. CAD develops when plaque builds up in the vessel blocking blood flow and oxygen supply to the heart requiring vessel interventions.
Currently, physicians often use several therapy approaches to clear calcified arterial blockages, including cutting balloons and atherectomy technology. IVL is a newer treatment for calcified coronary arteries that treats blockages by fracturing the calcium within the artery wall, potentially allowing for vessel expansion and better stent placement. Abbott’s investigational Coronary IVL System uses high-energy sound pressure waves to treat calcium blockages prior to placing a stent.