Abbott has announced the completion of enrolment in the TECTONIC CAD IVL investigational device exemption (IDE) study, a pivotal trial evaluating the safety and effectiveness of the company’s SonicForce coronary intravascular lithotripsy (IVL) system in patients with severely calcified, de novo coronary lesions prior to stent placement.
The TECTONIC CAD IVL trial enrolled 335 patients across 40 US clinical sites, with first pivotal trial data expected to be presented at the Transcatheter Cardiovascular Therapeutics (TCT) meeting later this year (31 October–3 November, San Diego, USA).
“Severe coronary calcium remains one of the most complex challenges facing interventional cardiologists, often making it more difficult to optimise stent delivery and expansion,” said Ethan Korngold, chief medical officer of Abbott’s Vascular business. “Completion of enrolment in the TECTONIC CAD IVL trial marks an important milestone as we evaluate the potential of the investigational SonicForce coronary IVL system. Together with our industry-leading Ultreon 3.0 intravascular imaging software, vessel preparation technologies, and Xience family of stents, we believe this innovation has the potential to further advance treatment options for physicians managing complex coronary artery disease and help improve patients’ outcomes.”
The SonicForce coronary IVL system is designed to use acoustic pressure waves to break hard calcium blockages in severely calcified coronary arteries to prepare the vessel for the stent placement.
“Intravascular lithotripsy is an emerging clinical tool designed to address calcified coronary artery disease,” said Eric Secemsky, director of vascular intervention in the Cardiovascular Institute at Beth Israel Deaconess Medical Center (Boston, USA). “The anticipated addition of the SonicForce coronary IVL system has the potential to advance the technologies built for the most complex lesion subtypes, that can assist us physicians in optimising care for our patients.”
