Abbott's TECTONIC clinical trial demonstrates strong 30-day outcomes and high procedural success for its investigational SonicForce™ Coronary Intravascular Lithotripsy System
Key Highlights
- ➤SonicForce trial met primary safety endpoint; 30-day target lesion failure was 0.3%
- ➤SonicForce achieved 97% procedural success in 335 severely calcified CAD patients
- ➤TECTONIC enrolled 335 patients across 40 U.S. sites
- ➤MACE was 0.3% in the as-treated population
- ➤SonicForce remains investigational and is not FDA-approved
Expert Statements
Eric A. Secemsky, Director of vascular intervention at Beth Israel Deaconess Medical Center and TECTONIC CAD trial co-principal investigator
“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.”
Eric A. Secemsky, Director of vascular intervention at Beth Israel Deaconess Medical Center and TECTONIC CAD trial co-principal investigator
“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.”
Julie Tyler, Senior vice president of Abbott's vascular business
“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.”
Abbott's TECTONIC clinical trial demonstrates strong 30-day outcomes and high procedural success for its investigational SonicForce™ Coronary Intravascular Lithotripsy System PR Newswire
* SonicForce is an investigational coronary intravascular lithotripsy (IVL) system that uses acoustic pressure waves, similar to those used to break up kidney stones, to crack calcium in coronary arteries and restore blood flow * The system is designed to bring purposeful innovation to treating complex coronary calcium, with longer treatment lengths, more pulses and enhanced catheter deliverability * Approval of the investigational system would further strengthen Abbott's comprehensive coronary devices portfolio, complementing its advanced imaging, lesion preparation and stent technologies ABBOTT PARK, Ill., Nov. 1, 2026 /PRNewswire/ -- Abbott (NYSE: ABT), the global healthcare leader, announced 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(TM) 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.
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