Abbott Launches Clinical Trial for Coronary IVL System to Improve Treatment of Artery Disease

On March 24, 2025, Abbott announced FDA approval of an investigational device exemption (IDE) for its Coronary Intravascular Lithotripsy (IVL) System, allowing the company to initiate the TECTONIC clinical trial. The study will evaluate the safety and effectiveness of using sound pressure waves to treat severe calcification in coronary arteries prior to stent placement. Up to 335 patients across 47 U.S. sites will be enrolled.

Coronary artery disease (CAD) affects over 20 million adults in the U.S. and is the leading cause of death nationwide. Traditional interventions can struggle with heavy arterial calcium buildup. Abbott’s investigational IVL system aims to improve outcomes by modifying calcified plaques to optimize stent deployment.

The IVL system builds on Abbott’s broader vascular portfolio, which includes diagnostic and therapeutic tools like optical coherence tomography (OCT) imaging. The company emphasizes its continued commitment to advancing cardiovascular care through new technologies.

Abbott’s Coronary IVL System is currently investigational and not yet commercially available.