Abbott will be trying its hand in the growing field of intravascular lithotripsy, with a clinical study to examine an unnamed, investigational system that aims to fracture hardened calcium within the heart’s coronary arteries.
According to the company, its approach will employ high-energy sound pressure waves to crack obstructive deposits within the blood vessel, before the placement of a stent. The study, dubbed TECTONIC, is slated to enroll up to 335 people with coronary artery disease across the U.S.
Abbott said the technology will build upon its current portfolio for managing heart disease, which includes drug-eluting stents as well as optical coherence tomography-equipped imaging catheters, or OCT.
The company also currently markets its Diamondback 360 atherectomy platform, designed to clear paths through blocked peripheral vessels. That device—acquired in 2023 through the $890 million purchase of its developer, Cardiovascular Systems—uses a rotating burr to sand away calcium from the artery walls.
However, last October, a large, randomized study that aimed to adapt the Diamondback’s orbital approach to the coronary arteries failed to outperform traditional, balloon-based angioplasty. The ECLIPSE trial, presented as a late-breaking study at the TCT conference, had enrolled about 2,000 patients over six years.
Orbital atherectomy resulted in longer procedure times but did not lead to the placement of wider drug-eluting stents—cross-section averages of stent area were similar at the sites within the vessel that had had the most calcium. At the same time, patients did not see statistically significant differences in the rate of their arteries renarrowing after one year.
Meanwhile, intravascular lithotripsy has attracted significant attention: Johnson & Johnson inked the largest medtech acquisition deal of last year with its $13.1 billion buy of Shockwave Medical. J&J has since pitched the company’s portfolio—with sonic-powered catheters for both the coronary and peripheral arteries—as a potentially billion-dollar vascular venture.
Boston Scientific is also looking to complete, with its $664 million purchase of developer Bolt Medical and its investigational, laser-based hardware announced this past January.