Abbott Reports TECTONIC Trial 30-Day Results: SonicForce Coronary IVL System Achieves 97% Procedural Success
Abbott, headquartered in Abbott Park in Lake County, Illinois, announced on November 1 that its pivotal TECTONIC Coronary Artery Disease (CAD) Intravascular Lithotripsy (IVL) Investigational Device Exemption (IDE) study met its prespecified primary safety and effectiveness endpoints: the investigational SonicForce Coronary IVL System recorded a 30-day target lesion failure rate of just 0.3% and a procedural success rate of 97% in patients with severely calcified coronary lesions.
The study enrolled 335 patients with severely calcified coronary artery disease at 40 U.S. sites, evaluating the system for modifying calcium buildup in narrowed coronary arteries before stent placement. Intravascular lithotripsy is a minimally invasive technique that uses acoustic pressure waves, similar to the technology used to break up kidney stones, to crack hardened plaque; the SonicForce system delivers up to 160 pulses at two pulses per second through a balloon-mounted catheter.
The primary safety endpoint, 30-day target lesion failure, was 0.3%, and the primary effectiveness endpoint, procedural success, was 97%. Major adverse cardiovascular events, a composite of cardiac death, myocardial infarction and target vessel revascularization, were 0.3% in the as-treated population. A prespecified optical coherence tomography (OCT) imaging substudy of 106 patients identified calcium fractures within lesions after treatment and showed improved post-stent expansion.
The results were presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Diego from October 31 to November 3 and published simultaneously in JACC: Cardiovascular Interventions. Eric A. Secemsky, director of vascular intervention at Beth Israel Deaconess Medical Center in Boston and a co-principal investigator of the trial, said severely calcified lesions remain among the most challenging scenarios in coronary intervention and that the data add new evidence for managing such patients.
Abbott said the SonicForce system remains investigational and has not been approved by the U.S. Food and Drug Administration; its use in the United States is limited to investigational settings, and the company has not disclosed a regulatory submission timeline.
Published by GSM · USA (original Chinese edition)
Photo: 冠状动脉粥样硬化示意图。美国国家心肺血液研究所（NHLBI）绘制，公共领域，经 Wikimedia Commons。 / Diagram of coronary artery atherosclerosis. Drawn by the National Heart, Lung, and Blood Institute (NHLBI), public domain, via Wikimedia Commons.
