Nov. 1, 2026 – Abbott has announced the 30-day results from the TECTONIC Coronary Artery Disease (CAD) Intravascular Lithotripsy (IVL) Investigational Device Exemption (IDE) Study evaluating the use of its investigational SonicForce Coronary IVL System, which is designed to crack calcium buildup in coronary arteries. 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 the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Diego and simultaneously published in the Journal of the American College of Cardiology: Cardiovascular Interventions.
The TECTONIC study enrolled 335 patients with severely calcified CAD across 40 U.S. sites and evaluated the investigational SonicForce Coronary IVL System in people with narrowed coronary arteries caused by calcium buildup. Key data from the trial include:
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The study met its primary safety endpoint, with a low 30-day target lesion failure rate of 0.3%.
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The study achieved its primary effectiveness endpoint, 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 less than 50% for all patients assessed by core laboratory and major adverse cardiovascular events (MACE; composite of cardiac death, all myocardial infarction, target vessel revascularization) of 0.3% of patients in the as-treated population.
IVL is a minimally invasive medical procedure that uses acoustic pressure waves, similar to technology used for kidney stones, to crack hard plaque in narrowed heart vessels. In a prespecified imaging sub-study of 106 patients, optical coherence tomography (OCT) imaging identified calcium fractures within lesions following treatment with the investigational SonicForce Coronary IVL System and showed improved post-stent expansion.
TECTONIC Clinical Trial
"Coronary calcium remains one of the greatest challenges to achieving optimal percutaneous coronary intervention outcomes," said Eric A. Secemsky, MD, MSc, RPVI, FACC, FAHA, FSCAI, FSVM, director of vascular intervention at the Cardiovascular Institute, Beth Israel Deaconess Medical Center in Boston and co-principal investigator for the TECTONIC CAD IVL trial. "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."
“The investigational SonicForce System has the potential to expand Abbott’s broad range of access-to-closure devices, strengthen our leadership in treating severely calcified coronary arteries, and reinforce our commitment to equip physicians with integrated solutions for patients at every stage of care,” said Julie Tyler, senior vice president of Abbott’s vascular business.
The SonicForce System approval would further expand Abbott’s portfolio of technologies designed to support complex cardiovascular disease.
November 02, 2026 
