TECTONIC Studies Abbott’s SonicForce Coronary IVL System to Treat CAD

November 1, 2026—Abbott announced 30-day results from the TECTONIC investigational device exemption (IDE) study of the company’s SonicForce coronary intravascular lithotripsy (IVL) system in the treatment of coronary artery disease (CAD). The investigational SonicForce system is designed to crack calcium buildup in coronary arteries.

According to the company, the study met its primary safety and effectiveness endpoints, demonstrating excellent early clinical outcomes in patients with severe coronary calcification.

Results from the TECTONIC CAD IVL IDE study were presented at TCT 2026 and simultaneously published by Eric A. Secemsky, MD, et al in Journal of the American College of Cardiology: Cardiovascular Interventions.

The TECTONIC investigators enrolled 335 patients with severely calcified CAD across 40 sites in the United States. The study evaluated the investigational SonicForce coronary IVL system in patients with narrowed coronary arteries caused by calcium buildup.

As summarized in Abbott’s press release, key data from the trial include the following:

• The primary safety endpoint was met with a 30-day target lesion failure rate of 0.3%.
• The primary effectiveness endpoint was met with high procedural success in 97% of patients.
• Key secondary endpoints were also met, including post-IVL stent delivery with remaining vessel blockage dropping to < 50% for all patients assessed by core laboratory and a major adverse cardiovascular event (a composite of cardiac death, all myocardial infarction, target vessel revascularization) rate of 0.3% of patients in the as-treated population.

Additionally, the company noted that a prespecified imaging substudy of 106 patients used optical coherence tomography imaging to identify calcium fractures within lesions after treatment with SonicForce and showed improved poststent expansion.

“Coronary calcium remains one of the greatest challenges to achieving optimal percutaneous coronary intervention outcomes,” commented the study’s Coprincipal Investigator Eric A. Secemsky, MD, in the Abbott press release. “The TECTONIC CAD data suggest that Abbott's investigational SonicForce coronary IVL system may provide physicians with a safe and effective approach to modifying severe coronary calcification prior to stenting. For operators treating increasingly complex coronary disease, this product has the potential to expand the tools available for treatment options and meaningfully improve procedural success and patient care.”