Abbott's TECTONIC Trial of SonicForce Coronary IVL Meets Endpoints With 0.3% Lesion Failure

Abbott said on November 1, 2026 that its TECTONIC study of the investigational SonicForce Coronary Intravascular Lithotripsy System met its primary safety and effectiveness endpoints, with a 0.3% 30-day target lesion failure rate and procedural success in 97% of patients. The results were presented at the TCT 2026 conference in San Diego, PR Newswire reported.

Inside the TECTONIC Study Results

The TECTONIC Coronary Artery Disease Intravascular Lithotripsy Investigational Device Exemption Study enrolled 335 patients with severely calcified coronary artery disease across 40 U.S. Sites. The study evaluated the SonicForce system in people with narrowed coronary arteries caused by calcium buildup. Results were presented at TCT, held October 31 to November 3, 2026, and published simultaneously in the Journal of the American College of Cardiology: Cardiovascular Interventions.

Key secondary endpoints were also met. Post-IVL stent delivery left remaining vessel blockage below 50% for all patients assessed by core laboratory, and major adverse cardiovascular events occurred in 0.3% of patients in the as-treated population. In a prespecified imaging sub-study of 106 patients, optical coherence tomography identified calcium fractures within lesions after treatment and showed improved post-stent expansion.

SonicForce uses acoustic pressure waves, similar to technology used to break up kidney stones, to crack calcium in coronary arteries and restore blood flow. The system is designed with longer treatment lengths, more pulses and enhanced catheter deliverability, and delivers up to 160 pulses at two pulses per second. The system has not been approved by the U.S. Food and Drug Administration and is limited by federal law to investigational use.

"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," said Eric A. Secemsky, director of vascular intervention at the Cardiovascular Institute, Beth Israel Deaconess Medical Center in Boston and co-principal investigator for the trial. Julie Tyler, senior vice president of Abbott's vascular business, said the system "has the potential to expand Abbott's broad range of access-to-closure devices."

Abbott's Recent Trial and Portfolio Moves

Abbott initiated the CROWN-MV pivotal trial for its Cephea mitral valve replacement device on October 29, 2026, enrolling up to 585 patients in the U.S., Canada and Europe, Stock Titan reported. The study targets patients with symptomatic mitral valve disease who cannot undergo surgery or transcatheter repair.

On October 23, 2026, Abbott presented Beta-CORRECT data at ESMO 2026 showing its whole-genome sequencing Oncodetect test improved colorectal cancer recurrence detection sensitivity by 30% absolute over whole-exome sequencing, PR Newswire reported. The company is also spinning off an $8.5 billion business, with Columbus designated as the hub for its U.S. Production, according to American City Business Journals on October 23, 2026.

SonicForce's Regulatory Path

Abbott describes SonicForce as an investigational system, and the TECTONIC results were presented at a conference running through November 3, 2026. The company's announcement states that approval would further expand its portfolio of technologies for complex cardiovascular disease.