Key result
SonicForce intravascular lithotripsy achieves ~97% procedural success with minimal 30-day target lesion failure.
Why the study?
Severe coronary calcification complicates percutaneous coronary intervention by limiting lesion compliance and impairing stent expansion, motivating an evaluation of the safety and effectiveness of the SonicForce Coronary Intravascular Lithotripsy System in severely calcified de novo coronary lesions.
Does the SonicForce Coronary Intravascular Lithotripsy System achieve low 30-day target lesion failure and high procedural success in patients with severely calcified de novo coronary lesions?
Does the SonicForce Coronary Intravascular Lithotripsy System achieve low 30-day target lesion failure and high procedural success in patients with severely calcified de novo coronary lesions?
The SonicForce Coronary Intravascular Lithotripsy System demonstrated high procedural success (97.0%) and low 30-day target lesion failure (0.3%), effectively fracturing calcium and facilitating stent expansion in severely calcified de novo coronary lesions.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Severe coronary calcium remains one of the most complex challenges facing interventional cardiologists, often making it more difficult to optimize stent delivery and expansion. Completion of enrollment in the TECTONIC CAD IVL trial marks an important milestone as we evaluate the potential of the investigational SonicForce Coronary IVL System.”
“Coronary calcium remains one of the greatest challenges to achieving optimal percutaneous coronary intervention outcomes. 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. 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.”
“OCT and IVUS demonstrated calcium modification and facilitated lumen and stent expansion, providing mechanistic support for the procedural findings.”
Hypothesis-generating in CAD; leaves open prospective validation before any clinical role.
Background Severe coronary calcification complicates percutaneous coronary intervention by limiting lesion compliance and impairing stent expansion. Objectives To evaluate the safety and effectiveness of the SonicForce Coronary Intravascular Lithotripsy System (Abbott Vascular) in severely calcified de novo coronary lesions. Methods TECTONIC CAD intravascular lithotripsy investigational device exemption (NCT06885177) was a prospective, multicenter, single-arm study of 335 patients at 40 U.S. centers. The primary safety endpoint was 30-day target lesion failure, defined as cardiac death, target-vessel myocardial infarction, or clinically driven target lesion revascularization. The primary effectiveness endpoint was procedural success. Each endpoint was tested against a prespecified performance goal. A prespecified optical coherence tomography (OCT) substudy evaluated calcium modification and stent expansion. Results A total of 335 patients were included in the full analysis set, with 330 and 334 as the evaluable populations for the primary safety and primary effectiveness endpoints, respectively, and a median follow-up duration of 36 days (Q1-Q3: 28-37 days). Thirty-day target lesion failure was 0.3% (1 of 330; exact 2-sided 95% CI: 0.0%-1.7%); the upper 1-sided 97.5% confidence bound was 1.7%, below the 12.9% performance goal (*P* < 0.0001). Procedural success was 97.0% (324 of 334; exact 2-sided 95% CI: 94.6%-98.6%); the lower 1-sided 97.5% confidence bound was 94.6%, above the 87.1% performance goal (*P* < 0.0001). In the OCT substudy, mean calcium length was 22.2 ± 10.3 mm, and the maximum contiguous calcium site had a calcium arc of 247.3 ± 99.0° and a thickness of 0.90 ± 0.25 mm at baseline. At this site, final stent area was 7.1 ± 1.9 mm 2 , with stent expansion of 95.9% ± 18.6%. Calcium fracture was identified in 62.5% (50 of 80) of lesions after intravascular lithotripsy and 66.3% (53 of 80) after stenting. Conclusions TECTONIC CAD met both prespecified coprimary safety and effectiveness endpoints, demonstrating low 30-day target lesion failure and high procedural success. OCT demonstrated calcium fracture and favorable stent expansion at maximum contiguous calcium.
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Secemsky et al. (2026) studied Severely calcified de novo coronary artery lesions (n=335). SonicForce Coronary Intravascular Lithotripsy System vs. Prespecified performance goals (single-arm study) was evaluated on Coprimary endpoints: 30-day target lesion failure (cardiac death, target-vessel MI, or clinically driven target lesion revascularization) and procedural success (95% CI 0.0-1.7, p=<0.0001). SonicForce intravascular lithotripsy achieved 0.3% 30-day target lesion failure and 97.0% procedural success in severely calcified coronary lesions, meeting both performance goals (P<0.0001).
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