Abbott (NYSE: ABT) has received an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to evaluate its Coronary Intravascular Lithotripsy (IVL) System. This system aims to treat severe calcification in coronary arteries before stenting. The TECTONIC Coronary Artery Disease (CAD) IVL clinical trial will enroll up to 335 participants across 47 sites in the United States.
Addressing the Burden of Coronary Artery Disease
Coronary Artery Disease (CAD) affects over 20 million adults in the U.S. and remains the leading cause of death. CAD develops when plaque accumulates in arteries, restricting blood flow and oxygen supply to the heart. In severe cases, medical intervention is required to restore circulation.
The Need for Innovative Treatment Approaches
Currently, physicians rely on various techniques, such as cutting balloons and atherectomy, to clear calcified blockages before placing a stent. Intravascular Lithotripsy (IVL) is an emerging technology that uses high-energy sound pressure waves to fracture calcium deposits in artery walls. This process facilitates vessel expansion and improves stent placement. Abbott’s investigational Coronary IVL System is designed to enhance this approach by offering a more effective way to modify calcified plaques.
TECTONIC CAD IVL Trial: Evaluating a New Treatment Option
Eric Secemsky, M.D., director of vascular intervention at the CardioVascular Institute, Beth Israel Deaconess Medical Center, and co-principal investigator of the TECTONIC CAD IVL trial, emphasized the significance of this study. He stated, “For people living with coronary artery disease, severe calcification complicates treatment and limits the effectiveness of standard interventions like angioplasty or stenting. This trial will evaluate a new method to prepare the vessel before stenting and optimize stent placement.”
Advancing Abbott’s Vascular Portfolio
As per the Abbott press release, Abbott continues to expand its innovative vascular treatment solutions. The company already offers Optical Coherence Tomography (OCT) imaging technology, which helps physicians detect calcium buildup and assess arteries for plaque modification. By integrating its investigational Coronary IVL System, Abbott aims to improve patient outcomes. The system ensures complete vascular assessment, preparation, and treatment.
Commitment to Innovation in Cardiovascular Care
Jennifer Jones-McMeans, Ph.D., divisional vice president of global clinical affairs at Abbott’s vascular business, highlighted the company’s dedication to advancing coronary artery disease treatments. She stated, “Abbott leads in coronary artery disease management by providing cutting-edge diagnostics and therapeutic options for calcium detection and treatment at every stage. Through this study, we are exploring the next generation of calcium modification technology to make interventions safer and more effective.”
Future of Abbott’s Coronary IVL System
Abbott’s Coronary IVL System remains an investigational device and is not yet available for commercial use. However, through rigorous clinical evaluation, the company aims to develop a next-generation solution for treating calcified coronary arteries. It also seeks to improve patient care.