Abbott's SonicForce meets both endpoints in pivotal coronary calcium trial

Overview

Updated 1 hour ago

Calcium hardened into a coronary artery wall stops balloons from opening and stents from seating properly. Abbott's SonicForce attacks that calcium with acoustic pressure waves, the same physics used to break up kidney stones, and in a 335-patient U.S. study it met both of its primary endpoints.

Thirty-day target lesion failure was 0.3%, against a prespecified performance goal of 12.9%. Procedural success was 97.0%, against a goal of 87.1%. The results were presented at a conference in San Diego and published in JACC: Cardiovascular Interventions, and Abbott says they support a U.S. market approval filing.

Why it matters

A second coronary lithotripsy supplier would give U.S. hospitals leverage against Johnson & Johnson's Shockwave, which has had the market largely to itself.

Questions about this story

Free account needed to ask — your question is kept and asked for you right after sign-up. Answers are public.

No questions yet — be the first to ask.

Key Indicators

0.3%

30-day target lesion failure

One event among 330 evaluable patients; the performance goal was 12.9%.

97.0%

Procedural success

324 of 334 evaluable patients; the performance goal was 87.1%.

335

Patients enrolled

Single-arm study across 40 U.S. centers.

66.3%

Calcium fracture after stenting

53 of 80 lesions in the optical coherence tomography substudy.

95.9%

Stent expansion at maximum calcium

Measured at the site with the largest contiguous calcium arc.

Voices

Curated perspectives — historical figures and your fellow readers.

Organizations Involved

Abbott Laboratories

Medical device and diagnostics manufacturer

Sponsor of the TECTONIC CAD trial; seeking U.S. approval for SonicForce

Abbott makes stents, heart valves, guidewires and diagnostic tests, and already sells orbital atherectomy catheters for calcified arteries.

Shockwave Medical

Medical device maker, part of Johnson & Johnson MedTech

Incumbent coronary lithotripsy supplier

Shockwave built the first coronary intravascular lithotripsy system and was acquired by Johnson & Johnson in 2024.

U.S. Food and Drug Administration

Federal regulator

Would review any Abbott premarket approval application for SonicForce

The FDA reviews premarket approval applications for high-risk cardiovascular devices before they can be sold in the United States.

Timeline

2 events Latest: Today

November 2026
TECTONIC CAD meets both primary endpoints
Today Clinical results

Abbott reported 0.3% 30-day target lesion failure and 97.0% procedural success in 335 patients across 40 U.S. centers.
Today
Imaging substudy shows calcium fracture in two-thirds of lesions
Today Clinical results

Optical coherence tomography found calcium fracture in 66.3% of 80 assessed lesions after stenting, with 95.9% stent expansion.
Today

Scenarios

FDA approves SonicForce for severely calcified coronary lesions

Likely Resolves by End of 2027

Discussed by: Abbott and the TECTONIC CAD investigators, who designed the single-arm study against prespecified performance goals to support market approval

Abbott submits a premarket approval application built on the 335-patient TECTONIC data, and the FDA clears the device for use before stenting in severely calcified de novo lesions. Approval would make SonicForce the second coronary lithotripsy system sold in the United States and the first direct competitor to Shockwave.

FDA convenes an advisory panel before deciding on SonicForce

Possible Resolves by Q2 2027

Discussed by: Device industry analysts watching the coronary lithotripsy category

The FDA refers the application to its Circulatory System Devices Panel, adding a public meeting and several months to the review. A panel would focus attention on the single-arm design, which has no randomized comparison group, and on the small number of clinical events in the trial.

Two-year TECTONIC data show target lesion failure above 5%

Unlikely Resolves by End of 2028

Discussed by: The TECTONIC CAD authors, who note that follow-up through two years is ongoing and needed to test durability

The 30-day event rate was built on a single event. If late failures, restenosis or stent thrombosis accumulate as follow-up extends, the device's early advantage narrows and the case for broad use weakens. The trial protocol excludes heart attack patients, cardiogenic shock and dialysis patients, so longer data would also test how the results hold outside the studied population.

Historical Context

3 moments from history that rhyme with this story — and how they unfolded.

2021

Disrupt CAD III (2021)

Shockwave Medical ran the first pivotal U.S. trial of a coronary lithotripsy balloon, treating severely calcified lesions before stenting. The study reported 92.2% freedom from major adverse cardiac events at 30 days and 92.4% procedural success.

Then

The results supported U.S. market approval for Shockwave's coronary system, making lithotripsy an alternative to atherectomy and specialty balloons.

Now

Shockwave became the dominant coronary lithotripsy supplier, and Johnson & Johnson acquired the company in 2024.

Why this matters now

Disrupt CAD III is the benchmark every coronary lithotripsy trial is now measured against, and TECTONIC's lower event rate is the comparison Abbott will make to regulators and hospitals.

Early 1980s

Extracorporeal shock wave lithotripsy (early 1980s)

Clinicians in Germany began using focused acoustic shock waves to shatter kidney stones without surgery, an approach that became a standard urology treatment.

Then

Patients avoided open surgery for a common and painful condition.

Now

The physics of focused pressure waves became a platform technology, later adapted to break calcium inside blood vessels.

Why this matters now

Coronary lithotripsy is a direct descendant of that work, which is why Abbott's press materials compare the device to kidney stone treatment.

1990s

Rotational atherectomy (1990s)

Diamond-tipped burrs that drill through calcified plaque entered cardiology practice as the first dedicated tool for lesions balloons could not open.

Then

Operators gained a way to modify calcium, but the procedure required specialized technique and carried risks of burr entrapment and slow flow.

Now

Atherectomy remained a niche tool used by experienced operators, leaving room for balloon-based alternatives.

Why this matters now

Atherectomy is the incumbent approach lithotripsy competes with, and Abbott already sells an orbital atherectomy system alongside the SonicForce program.