New Heart Devices Show Strong Early Trial Results

Adults with atrial fibrillation or calcified coronary artery disease may benefit once these investigational devices reach clinical use.

Updated on Nov. 2, 2026 in Heart Disease

Bold vector editorial illustration of a slender catheter tip with an umbrella-shaped lobe and a coiled wire emitting pressure rings, in teal, coral, and cream. — Abbott Laboratories reported positive early trial results for two investigational heart devices, one for atrial fibrillation and one for calcified coronary artery disease. AI Illustration. Upload story photo >

Abbott Laboratories reported positive clinical trial results for two investigational cardiovascular devices. The Amulet 360 Left Atrial Appendage Occluder, designed to treat non-valvular atrial fibrillation, achieved complete closure with no leak in 96.3% of patients, while the SonicForce Coronary Intravascular Lithotripsy System showed a 97% procedural success rate in patients with severely calcified coronary artery disease.

Why it matters

Atrial fibrillation and calcified coronary artery disease are both common reasons for stroke and heart complications, so new options for treating them carry real stakes for patients and their care teams. The results were presented as investigational trial data, meaning the devices are not yet available for routine use.

The Amulet 360 results come from the VERITAS study and the SonicForce results from the 335-patient TECTONIC Investigational Device Exemption study, both reported as investigational device data. Outcomes were measured at 30 days for SonicForce and through one year for Amulet 360, and the source does not provide a control-group comparison.

The players

Abbott Laboratories

A major medical device and diagnostics company with a significant cardiovascular business spanning heart rhythm and coronary intervention technologies.

Transcatheter Cardiovascular Therapeutics (TCT)

A leading annual scientific conference where interventional cardiologists present clinical research on catheter-based heart procedures.

The details

The SonicForce system uses acoustic pressure waves to fracture hard calcium deposits that narrow coronary vessels, after which a stent can be placed to restore blood flow. The Amulet 360 was built on existing occlusion technology and features a softer, more conformable lobe along with an outer disc that adds a secondary sealing layer to close off the left atrial appendage, a small pouch in the heart where clots can form in atrial fibrillation.

Abbott announced the TECTONIC SonicForce 30-day outcomes on Sunday, November 1, 2026.
VERITAS Amulet 360 data was presented at the TCT conference in San Diego on Monday, November 2, 2026.

Health Landscape

Left atrial appendage occluders are positioned as an alternative for patients with atrial fibrillation who cannot take long-term blood thinners, and the Amulet 360 is a next-generation entry in that device category. Catheter-based treatment of calcified coronary disease is itself an evolving area, with lithotripsy offering a way to treat vessels that stents alone have difficulty opening.

If you have atrial fibrillation and have been told you may be a candidate for a device rather than long-term blood thinners, these trial results are worth raising with your cardiologist. People with severely calcified coronary artery disease who are being evaluated for stenting may also want to ask whether newer approaches like lithotripsy are appropriate for their case.

The takeaway

Investigational devices show promising early results, but they remain in trials and are not yet standard care. If you have atrial fibrillation or coronary artery disease, discuss your options and any emerging treatments with your cardiologist.