Abbott's TECTONIC clinical trial demonstrates strong 30-day outcomes and high procedural success for its investigational SonicForce™ Coronary Intravascular Lithotripsy System
The 335-patient trial reported 97% procedural success; SonicForce remains limited to investigational use.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Abbott (NYSE: ABT) reported that its investigational SonicForce coronary calcium-treatment system met both primary endpoints in the TECTONIC clinical trial.
The study enrolled 335 patients at 40 U.S. sites with severely calcified coronary artery disease. The primary safety endpoint showed a 0.3% 30-day target lesion failure rate, while the primary effectiveness endpoint showed 97% procedural success. Secondary endpoints were also met: remaining vessel blockage after treatment and stent delivery was less than 50% in all patients assessed by the core laboratory. Major adverse cardiovascular events occurred in 0.3% of the as-treated population.
SonicForce uses acoustic pressure waves to crack calcium before stent placement. It has not received FDA approval and remains limited to investigational use. Results were presented at TCT and published in JACC: Cardiovascular Interventions.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Major pointPrimary safety endpoint met with a 0.3% 30-day target lesion failure rate.
- Major pointPrimary effectiveness endpoint met with 97% procedural success.
- Minor pointSecondary endpoint met: remaining blockage was less than 50% after treatment and stent delivery in all core-laboratory-assessed patients.
- Minor pointMajor adverse cardiovascular events affected 0.3% of the as-treated population, meeting a secondary endpoint.
- Minor pointPrespecified imaging study of 106 patients identified calcium fractures after treatment and improved post-stent expansion.
Negative
- None.
AI-generated analysis. How Rhea-AI works. Not financial advice.
- 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 SonicForceTM 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.
Results from the TECTONIC CAD IVL IDE Study were presented today at the Transcatheter Cardiovascular Therapeutics (TCT) conference in
The TECTONIC study enrolled 335 patients with severely calcified CAD across 40 U.S. sites and evaluated the investigational SonicForce Coronary IVL System in people with narrowed coronary arteries caused by calcium buildup. Key data from the trial include:
- The study met its primary safety endpoint, with a low 30-day target lesion failure rate of
0.3% . - The study achieved its primary effectiveness endpoint, with high procedural success in
97% of patients. - Key secondary endpoints were also met, including post-IVL stent delivery with remaining vessel blockage dropping to less than
50% for all patients assessed by core laboratory and major adverse cardiovascular events (MACE; composite of cardiac death, all myocardial infarction, target vessel revascularization) of0.3% of patients in the as-treated population.
IVL is a minimally invasive medical procedure that uses acoustic pressure waves, similar to technology used for kidney stones, to crack hard plaque in narrowed heart vessels. In a prespecified imaging sub-study of 106 patients, optical coherence tomography (OCT) imaging identified calcium fractures within lesions following treatment with the investigational SonicForce Coronary IVL System and showed improved post-stent expansion.
"Coronary calcium remains one of the greatest challenges to achieving optimal percutaneous coronary intervention outcomes," said Eric A. Secemsky, MD, MSc, RPVI, FACC, FAHA, FSCAI, FSVM, director of vascular intervention at the Cardiovascular Institute, Beth Israel Deaconess Medical Center in
"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," said Julie Tyler, senior vice president of Abbott's vascular business.
The SonicForce System approval would further expand Abbott's portfolio of technologies designed to support complex cardiovascular disease.
Frequently Asked Questions
Q: What did the TECTONIC study show?
A: The TECTONIC Coronary Artery Disease (CAD) Intravascular Lithotripsy (IVL) Investigational Device Exemption (IDE) Study met its primary safety and effectiveness endpoints, demonstrating positive results for Abbott's investigational SonicForce™ Coronary IVL System. The study enrolled 335 patients with severe coronary artery calcification across 40 U.S. sites and reported a low 30-day target lesion failure rate of
Q: What is the SonicForce™ Coronary IVL System and how does it work?
A: Abbott's investigational SonicForce Coronary Intravascular Lithotripsy (IVL) System uses IVL, a technology that delivers acoustic pressure waves to crack calcium buildup within coronary arteries. Adapted from technology used to treat kidney stones, the system uses a balloon-mounted catheter to deliver acoustic pressure waves that modify calcium deposits. SonicForce Coronary IVL System is designed with features intended to support treatment of calcified lesions and delivery of up to 160 pulses at two pulses per second that helps facilitate vessel preparation.
Q: Why is this technology important for treating coronary artery disease?
A: Coronary artery disease (CAD) affects more than 20 million adults in
SonicForce Coronary IVL System has not been approved by the
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com and on LinkedIn, Facebook, Instagram, X and YouTube.
1 Nowbar, A.N., et al., Mortality From Ischemic Heart Disease. Circ Cardiovasc Qual Outcomes, 2019. 12(6): p. e005375.
2 Tsao, C.W., et al., Heart Disease and Stroke Statistics-2023 Update: A Report From the American Heart Association. Circulation, 2023. 147(8): p. e93-e621.
3 Brown JC, Gerhardt TE, Kwon E. Risk factors for coronary artery disease. PubMed. Published January 23, 2023. https://www.ncbi.nlm.nih.gov/books/NBK554410/
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FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did Abbott's TECTONIC trial show for SonicForce?
TECTONIC met its primary safety and effectiveness endpoints, reporting 0.3% target lesion failure at 30 days and 97% procedural success. The trial enrolled 335 patients with severely calcified coronary artery disease across 40 U.S. sites.
Is Abbott's SonicForce coronary lithotripsy system FDA-approved?
SonicForce has not been approved by the FDA and is limited by federal law to investigational use. The system uses acoustic pressure waves to crack calcium buildup within coronary arteries before stent placement.
What did the TECTONIC imaging substudy show about Abbott's SonicForce?
A prespecified substudy of 106 patients identified calcium fractures within treated lesions and showed improved post-stent expansion. It used optical coherence tomography, an imaging technique, to assess the arteries.