Abbott has reported positive 30-day results from the TECTONIC CAD IVL investigational device exemption (IDE) study, evaluating the use of its investigational SonicForce coronary IVL system.
The results have been reported at the Transcatheter Cardiovascular Therapeutics (TCT) conference (31 October–3 November, San Diego, USA) and are simultaneously published in JACC: Cardiovascular Interventions.
The TECTONIC study enrolled 335 patients with severely calcified coronary artery disease (CAD) across 40 US sites. The study met its primary safety endpoint, with a 30-day target lesion failure rate of 0.3%, as well as achieving procedural success in 97% of patients.
Key secondary endpoints were also met, including post-IVL stent delivery with remaining vessel blockage dropping to less than 50% for all patients assessed by core laboratory and major adverse cardiovascular events (MACE; composite of cardiac death, all myocardial infarction, target vessel revascularization) of 0.3% of patients in the as-treated population.
“Coronary calcium remains one of the greatest challenges to achieving optimal percutaneous coronary intervention outcomes,” said Eric Secemsky (Beth Israel Deaconess Medical Center, Boston, USA), 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. For operators treating increasingly complex coronary disease, this product has the potential to expand the tools available for treatment options and meaningfully improve procedural success and patient care.”
“The investigational SonicForce System has the potential to expand Abbott’s broad range of access-to-closure devices, strengthen our leadership in treating severely calcified coronary arteries, and reinforce our commitment to equip physicians with integrated solutions for patients at every stage of care,” said Julie Tyler, senior vice president of Abbott’s vascular business.
