TECTONIC IDE Trial of Abbott’s Coronary IVL Device Completes Enrollment 

April 21, 2026—Abbott Vascular has completed patient enrollment in the TECTONIC coronary artery disease (CAD) intravascular lithotripsy (IVL) investigational device exemption (IDE) study of the company’s new coronary IVL system in the treatment of severe calcification in coronary arteries before stenting.

The company advised it will continue follow-up in the 335-patient trial and prepare for a submission for premarket approval from the FDA. Julie Tyler, Senior Vice President and President of Abbott’s Vascular Business, announced the milestone in a LinkedIn posting.

In March 2025, the company announced it received FDA approval for the TECTONIC CAD IVL IDE trial to enroll up to 335 patients across 47 sites in the United States. In that announcement, Abbott Vascular stated that the coronary IVL system uses high-energy sound pressure waves to treat arterial calcium blockages.

The investigational device is not commercially available, advised Abbott Vascular.