Abbott has posted positive 30-day results from its Tectonic trial of the investigational SonicForce Coronary IVL System in coronary artery disease (CAD), but analysts urge caution on results.
The study met its primary safety and efficacy endpoints and showed “excellent early clinical outcomes in patients with severe coronary calcification,” according to an Abbott release.
The device is built with Abbott’s SonicForce technology, an investigational coronary intravascular lithotripsy (IVL) system that uses acoustic pressure waves similar to those used to break up kidney stones to crack calcium in coronary arteries and restore blood flow to crack calcium buildup in coronary arteries.
The Tectonic study enrolled 335 patients with severely calcified CAD across 40 U.S. sites and evaluated the use of SonicForce in people with narrowed coronary arteries caused by calcium buildup.
The study met its primary safety endpoint, with a low 30-day target lesion failure rate of 0.3%. It also achieved its primary efficacy endpoint, with high procedural success in 97% of patients.
However, analysts from Evercore ISI cautioned that calcified lesion lengths used in the trial were smaller compared to clinical data from Johnson & Johnson’s Disrupt CAD III and Boston Scientific’s Fracture products and had “an impact on the end points.”
Results from the study were published in the Journal of the American College of Cardiology: Cardiovascular Interventions.
"Coronary calcium remains one of the greatest challenges to achieving optimal percutaneous coronary intervention outcomes," said Eric A. Secemsky, MD, MSc, RPVI, FACC, FAHA, FSCAI, FSVM, director of vascular intervention at the Cardiovascular Institute, Beth Israel Deaconess Medical Center in Boston and co-principal investigator for the TECTONIC CAD IVL trial.
"The TECTONIC CAD data suggest that Abbott's investigational SonicForce Coronary IVL System may provide physicians with a safe and effective approach to modifying severe coronary calcification prior to stenting.”