ABBOTT PARK, Ill.– Abbott (NYSE: ABT) has announced the initiation of a new clinical trial evaluating its investigational Coronary Intravascular Lithotripsy (IVL) System for the treatment of severe calcification in coronary arteries. The U.S. Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) for this trial, which aims to enhance treatment options for patients with coronary artery disease (CAD).
The TECTONIC Coronary Artery Disease (CAD) Intravascular Lithotripsy (IVL) trial will enroll up to 335 patients across 47 U.S. sites. This pivotal study will assess the potential benefits of using the Coronary IVL System to treat calcified blockages in coronary arteries prior to stenting.
Coronary artery disease, the leading cause of death in the United States, affects over 20 million adults. The condition occurs when plaque builds up in the coronary arteries, restricting blood flow to the heart. For patients with severe arterial calcification, conventional treatments like angioplasty or stenting may not be effective, often due to the stiffness caused by calcium buildup.
The Coronary IVL System offers a promising solution by using high-energy sound waves to fracture calcium deposits in the arterial walls, which can facilitate better vessel expansion and improve stent placement. This treatment could enhance the outcomes of stenting procedures, making them more effective for patients with severe calcification.
Dr. Eric Secemsky, director of vascular intervention at Beth Israel Deaconess Medical Center in Boston and co-principal investigator for the trial, highlighted the importance of the study. “For patients with coronary artery disease, severe calcification can complicate treatment, often limiting the success of interventions like angioplasty or stenting. The TECTONIC trial will evaluate this innovative approach to preparing arteries before stenting, with the goal of optimizing stent placement and improving patient outcomes.”
Abbott’s investigational Coronary IVL technology is part of the company’s comprehensive vascular portfolio, which includes advanced diagnostic tools like optical coherence tomography (OCT) for detecting calcium buildup in arteries. Abbott’s integrated approach aims to address the challenges posed by coronary artery disease through a range of technologies designed for artery assessment, preparation, and treatment.
Jennifer Jones-McMeans, Ph.D., divisional vice president of global clinical affairs at Abbott’s vascular business, emphasized the company’s commitment to improving patient care. “Abbott is at the forefront of coronary artery disease treatment, offering cutting-edge solutions for calcium detection and management. With the launch of the Coronary IVL System, we are pushing the boundaries of calcium modification technology to improve safety and efficacy for patients.”
As an investigational device, Abbott’s Coronary IVL System is not yet commercially available. The TECTONIC trial will provide critical data on the potential of this technology to address the challenges of calcified coronary artery disease and further strengthen Abbott’s leadership in the vascular space.
