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# Abbott IDE OK’d for Coronary Artery Blockages Trial
- URL: https://www.fdaweb.com/abbott-ide-okd-for-coronary-artery-blockages-trial/
- Published: 2025-03-24T12:00:00.000Z
- Updated: 2026-09-14T14:56:02.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158876

FDA has approved an Abbott IDE for a clinical trial to evaluate its investigational coronary intravascular lithotripsy (IVL) system and its use for treating severe calcification in coronary arteries before stenting, which the company says could offer a new solution for patients with coronary artery disease (CAD). It says CAD is the most common heart disease in the country, affecting more than 20 million adults and the leading cause of death.

Abbott says the trial, named TECTONIC Coronary Artery Disease Intravascular Lithotripsy, will enroll up to 335 participants across 47 sites in the U.S. It will evaluate using high-energy sound pressure waves to fracture calcium buildup in the artery wall. “This method could improve vessel expansion and optimize stent placement, potentially enhancing treatment outcomes,” the company says, adding that physicians currently use various techniques to clear arterial blockages caused by calcification, including cutting balloons and atherectomy technology.