Abbott (NYSE:ABT) announced 30-day results from the TECTONIC Coronary Artery Disease Intravascular Lithotripsy Investigational Device Exemption Study on November 1, 2026, reporting that the trial met its primary safety and effectiveness endpoints for the investigational SonicForce Coronary IVL System.

Key Highlights

  • Primary safety endpoint met: The study reported a 30-day target lesion failure rate of 0.3%.
  • Primary effectiveness endpoint met: Procedural success was achieved in 97% of patients.
  • Trial size: The TECTONIC study enrolled 335 patients with severely calcified coronary artery disease across 40 U.S. sites.
  • MACE rate: Major adverse cardiovascular events (cardiac death, all myocardial infarction, target vessel revascularization) occurred in 0.3% of patients in the as-treated population.
  • Imaging sub-study: An optical coherence tomography imaging sub-study of 106 prespecified patients identified calcium fractures within lesions and showed improved post-stent expansion.
  • Investigational status: The SonicForce Coronary IVL System has not been approved by the U.S. Food and Drug Administration and is limited by federal law to investigational use.

TECTONIC Study Results and SonicForce IVL System Details

According to the filing, Abbott's TECTONIC CAD IVL IDE Study evaluated the investigational SonicForce Coronary IVL System in patients with narrowed coronary arteries caused by calcium buildup. The results were presented at the Transcatheter Cardiovascular Therapeutics conference in San Diego (October 31 through November 3, 2026) and simultaneously published in the Journal of the American College of Cardiology: Cardiovascular Interventions. The company disclosed that the study met all primary endpoints at the 30-day mark.

The filing described the SonicForce system as a balloon-mounted catheter device that delivers acoustic pressure waves, adapted from technology used to treat kidney stones, capable of delivering up to 160 pulses at two pulses per second. Key secondary endpoints reported as met include post-IVL stent delivery with remaining vessel blockage dropping to less than 50% for all patients assessed by core laboratory. Eric A. Secemsky, MD, co-principal investigator, was quoted in the filing as stating that "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."

Abbott senior vice president Julie Tyler was quoted as saying 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." The company noted that approval of the system would complement its existing coronary devices portfolio, including advanced imaging, lesion preparation, and stent technologies, though FDA approval has not yet been granted.

What Was Disclosed

Abbott disclosed 30-day clinical results from its TECTONIC CAD IVL IDE Study for the investigational SonicForce Coronary IVL System, including a 0.3% target lesion failure rate, 97% procedural success rate, and findings from a 106-patient OCT imaging sub-study, presented at TCT on November 1, 2026.