US healthcare company Abbott (NYSE:ABT) on Sunday reported strong 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, Abbott said.

Results from the TECTONIC CAD IVL IDE Study were presented on Sunday 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 US sites and evaluated the investigational SonicForce Coronary IVL System in people with narrowed coronary arteries caused by calcium buildup. According to Abbott, the study met its primary safety endpoint, with a low 30-day target lesion failure rate of 0.3%, and 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 revascularisation) of 0.3% of patients in the as-treated population.

Approval of the SonicForce System approval would further expand Abbott's portfolio of technologies designed to support complex cardiovascular disease.