Abbott's sound wave heart device hit 97% success in US trial

Abbott’s experimental sound wave device prepared a calcium hardened heart artery for a stent in 97% of patients in its US trial. The company reported the results Nov. 1 at the Transcatheter Cardiovascular Therapeutics meeting in San Diego.

The device is the SonicForce Coronary IVL System. IVL stands for intravascular lithotripsy, the kidney stone idea moved into a heart artery. A balloon on a catheter sends pressure waves that crack hard calcium so a stent can open fully.

Why it matters: this is the trial meant to win Abbott FDA approval in a market one company built. Johnson & Johnson agreed to buy Shockwave Medical, the IVL pioneer, for about $13.1 billion in April 2024. At the time, Shockwave had the only IVL system on the market.

The numbers

The trial, called TECTONIC, enrolled 335 patients with severely calcified coronary arteries at 40 US sites. Abbott reported:

• Procedural success: 97% of patients
• Target lesion failure at 30 days: 0.3%
• Major heart events at 30 days: 0.3% of the as treated group
• Remaining blockage after the stent: under 50% in every patient the core lab assessed

Target lesion failure counts cardiac death, a heart attack in the treated artery, or a repeat procedure on the treated spot. In an imaging substudy of 106 patients, scans showed cracks in the calcium and better stent expansion.

The fine print

TECTONIC had no comparison group. Every patient got the Abbott device, and the results are measured against performance goals set from published research, per the trial registry. Abbott sponsored the study.

The results are 30 days in. The registry lists the full study finishing in June 2028.

SonicForce is not FDA approved and is limited to investigational use. Abbott did not give a date for a filing or a launch.

The race

Shockwave now runs as a unit of Johnson & Johnson MedTech, after the deal closed May 31, 2024. J&J said it expected Shockwave to reach at least $1 billion in annual sales.

Abbott is pitching longer treatment lengths and more pulses: up to 160, at two per second. It would sell the system alongside its own artery imaging, lesion preparation tools and stents.

The short version: the pivotal test of Abbott’s answer to Shockwave met its goals, and the next fight is at the FDA.