Abbott has announced that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) for its Coronary Intravascular Lithotripsy (IVL) System. This system is set to be evaluated in the TECTONIC Coronary Artery Disease (CAD) Intravascular Lithotripsy clinical trial, which aims to treat severe calcification in coronary arteries before stenting. The trial will involve up to 335 participants across 47 sites in the United States.
Coronary Artery Disease (CAD) is a prevalent heart condition affecting over 20 million adults in the U.S., making it the leading cause of death in the country. CAD occurs when plaque accumulates in blood vessels, obstructing blood flow and oxygen supply to the heart, often necessitating medical interventions.
Current treatments for calcified arterial blockages include cutting balloons and atherectomy technology. However, IVL represents a newer approach by using sound pressure waves to fracture calcium within artery walls, potentially facilitating vessel expansion and improving stent placement. Abbott's investigational IVL System uses high-energy sound waves for this purpose.
Eric Secemsky, M.D., director of vascular intervention at the CardioVascular Institute at Beth Israel Deaconess Medical Center and co-principal investigator for the TECTONIC trial, stated: "For people living with coronary artery disease, severe calcification can make treatment more challenging, often limiting the effectiveness of standard interventions like angioplasty or stenting." He added that "the TECTONIC Coronary Artery Disease (CAD) Intravascular Lithotripsy (IVL) trial will evaluate a possible new treatment option to prepare the vessel prior to stenting and optimize stent placement."
Abbott's IVL technology expands on its existing vascular portfolio aimed at overcoming current challenges with available IVL systems. Their solutions include optical coherence tomography imaging technology that assesses coronary arteries for calcium buildup, assisting physicians in identifying arteries needing plaque modification.
Jennifer Jones-McMeans, Ph.D., divisional vice president of global clinical affairs at Abbott's vascular business said: "Abbott is a leader in treating coronary artery disease, offering the best diagnostics and therapeutic options for calcium detection and treatment at every stage." She noted that by working with physicians on evaluating Abbott's Coronary IVL System, they are "exploring the next generation of calcium modification technology."
The Coronary Intravascular Lithotripsy system remains an investigational device not yet available commercially.
Abbott is a global healthcare company with products spanning diagnostics, medical devices, nutritionals, and branded generic medicines. The company operates across more than 160 countries.