Abbott reports clinical trial results for SonicForce coronary lithotripsy system
Abbott’s investigational SonicForce IVL system met primary safety and effectiveness endpoints in the TECTONIC trial, showing a 97% procedural success rate in patients with severe coronary calcification.
Abbott has announced 30-day clinical outcomes from its TECTONIC trial, which evaluated the company’s investigational SonicForce Coronary Intravascular Lithotripsy (IVL) system. The study, involving 335 patients with severely calcified coronary artery disease across 40 U.S. sites, met its primary safety and effectiveness endpoints.
Data presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference indicated a 0.3% rate of target lesion failure at 30 days and a procedural success rate of 97%. The SonicForce system utilizes acoustic pressure waves, similar to technology used for kidney stones, to fracture calcium deposits within heart vessels, which allows for improved stent expansion during treatment.
Dr. Eric A. Secemsky, co-principal investigator of the trial, noted that the data suggest the system provides a viable approach for modifying coronary calcification prior to stenting. If approved, the device would expand Abbott's cardiovascular portfolio, which includes imaging and stent technologies, aimed at addressing complex coronary interventions.