Abbott’s TECTONIC trial reports 97% procedural success and 0.3% 30-day target lesion failure with its investigational SonicForce coronary IVL system.
Written By: Neha Vishwakarma, PharmD
Reviewed By: Pharmacally Editorial Team
Abbott reported on November 1, 2026, that its pivotal TECTONIC Coronary Artery Disease (CAD) Intravascular Lithotripsy (IVL) Investigational Device Exemption (IDE) study met both primary safety and effectiveness endpoints. Among 335 patients with severely calcified coronary lesions treated across 40 US centres, the investigational SonicForce Coronary IVL System achieved a 30-day target lesion failure (TLF) rate of 0.3% and procedural success of 97%.
The findings were presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Diego (October 31 to November 3, 2026) and published simultaneously in JACC: Cardiovascular Interventions. However, the single-arm study does not establish whether SonicForce performs better than existing intravascular lithotripsy or atherectomy devices. The system remains investigational and has not received US Food and Drug Administration (FDA) approval.
Addressing the challenge of calcified coronary arteries
Calcium accumulation within coronary artery walls can complicate percutaneous coronary intervention (PCI) by making stent delivery difficult and preventing adequate stent expansion. Incomplete stent expansion is associated with adverse clinical outcomes, making effective calcium modification an important step before stent placement.
Intravascular lithotripsy (IVL) addresses this challenge by delivering acoustic pressure waves through a balloon-mounted catheter to fracture calcium deposits within the vessel wall. The approach is adapted from lithotripsy technology used to break up kidney stones.
Abbott’s SonicForce system is designed with longer treatment lengths, increased pulse delivery and enhanced catheter deliverability. It can deliver up to 160 pulses at a frequency of two pulses per second.
TECTONIC trial design
TECTONIC was a pivotal IDE study evaluating the safety and effectiveness of SonicForce in patients with severely calcified, de novo coronary lesions requiring calcium modification before stent placement. The trial enrolled 335 patients across 40 US sites, with enrollment completed on August 4, 2026.
A prespecified optical coherence tomography (OCT) imaging substudy included 106 patients to assess calcium modification and post-stent expansion.
Clinical results: Both primary endpoints achieved
The study met its two primary endpoints:
- Primary safety endpoint: 30-day TLF rate of 0.3%.
- Primary effectiveness endpoint: Procedural success of 97%.
Key secondary findings included residual stenosis below 50% after IVL and stent delivery in all patients assessed by the core laboratory. Major adverse cardiovascular events (MACE), comprising cardiac death, all myocardial infarction and target vessel revascularization, occurred in 0.3% of the as-treated population.
The imaging findings provided additional evidence of calcium modification. The OCT substudy identified calcium fractures following SonicForce treatment and demonstrated improved post-stent expansion. The American College of Cardiology’s TCT 2026 coverage also reported that OCT and intravascular ultrasound (IVUS) demonstrated calcium modification and supported improved lumen and stent expansion.
Clinical interpretation and remaining evidence gaps
The low 30-day TLF and MACE rates, alongside 97% procedural success, provide encouraging early evidence of procedural feasibility and short-term safety in the studied population. The imaging findings further support the intended mechanism of IVL by demonstrating calcium fractures and improved stent expansion following treatment.
However, these findings require interpretation within the study’s limitations. TECTONIC was a single-arm study assessed against predefined performance goals, rather than a randomized comparison with other IVL systems or atherectomy. Therefore, the results cannot establish comparative efficacy or superiority.
The company announcement does not provide the numerical performance-goal thresholds, a detailed definition of procedural success, or individual rates of complications such as coronary dissection, perforation, slow-flow and no-reflow. Further information on final stent expansion measurements and the use of additional calcium-modification devices would also help assess procedural performance.
Additionally, the reported clinical outcomes cover only 30 days. Longer-term follow-up will be necessary to evaluate outcomes such as target lesion revascularization and stent thrombosis. The imaging substudy involved only 106 of the 335 enrolled patients, while the trial population was restricted to severely calcified, de novo coronary lesions. Consequently, the findings may not be generalizable to other complex coronary anatomies or lesion types.
Regulatory Status
Abbott said that potential approval of SonicForce would strengthen its coronary device portfolio, complementing its existing imaging, lesion preparation and stent technologies. However, the company has not disclosed a regulatory submission date or an expected FDA approval timeline.
Longer-term TECTONIC follow-up, additional real-world experience and comparative clinical studies will determine the system’s position among existing coronary calcium-modification technologies. Until regulatory clearance is obtained, SonicForce remains limited to investigational use in the United States.
References
Abbott’s TECTONIC clinical trial demonstrates strong 30-day outcomes and high procedural success for its investigational SonicForce™ Coronary Intravascular Lithotripsy System, Abbott, 01 November 2026
Secemsky, E, Ali, Z, Shlofmitz, E. et al. TECTONIC CAD: Pivotal IDE Evaluation of Coronary Intravascular Lithotripsy for Severely Calcified Lesions. J Am Coll Cardiol Intv. null2026, 0 (0). https://doi.org/10.1016/j.jcin.2026.10.002
TECTONIC CAD IVL IDE Study (TECTONIC), ClinicalTrials.gov ID NCT06885177
About the Writer
Neha Vishwakarma (LinkedIn) is a Pharm.D professional with experience in clinical pharmacy, pharmacovigilance, and clinical research. She has hands-on experience in ADR assessment, ICSR processing, medication safety, and clinical data evaluation. Her research background in surgical site infections and antibiotic use supports her focus on evidence-based healthcare writing.