Abbott Initiates TECTONIC IDE Trial Evaluating New Coronary IVL Device

March 24, 2025—Abbott announced it received approval from the FDA to proceed with its TECTONIC coronary artery disease (CAD) intravascular lithotripsy (IVL) investigative device exemption trial.

TECTONIC aims to evaluate the company’s new coronary IVL system in the treatment of severe calcification in coronary arteries before stenting. According to the company, the trial will enroll up to 335 patients across 47 sites in the United States.

“For people living with CAD, severe calcification can make treatment more challenging, often limiting the effectiveness of standard interventions like angioplasty or stenting,” commented Eric Secemsky, MD, Co-Principal Investigator of TECTONIC in the company’s announcement.

“The TECTONIC CAD IVL trial will evaluate a possible new treatment option to prepare the vessel prior to stenting and optimize stent placement.” Dr. Secemsky is the Director of Vascular Intervention at the CardioVascular Institute, Beth Israel Deaconess Medical Center in Boston, Massachusetts.

Abbott noted that its investigational coronary IVL system uses high-energy sound pressure waves to treat arterial calcium blockages.

The coronary IVL system is an investigational device and not commercially available.