SVP and President of Abbott Vascular, Julie Tyler, said on LinkedIn that the company’s TECTONIC coronary IVL study conducted under FDA investigational device exemption (IDE) successfully completed enrollment of all 335 patients anticipated.
“We are now one step closer to bringing a new and much-needed vessel preparation option to people with coronary artery disease (CAD),” Tyler wrote. “We will carry this momentum into our follow-up execution and the path toward our submission for premarket approval (PMA).”
Abbott announced in March 2025 that it received FDA IDE approval for its coronary IVL system. The company threw its hat in the ring of a growing space, currently led by Johnson & Johnson’s Shockwave Medical. Boston Scientific entered the space last year, agreeing to buy Bolt Medical in January. Stryker then made its IVL move, agreeing to buy Amplitude Vascular Systems this past week.
Other companies, such as FastWave Medical and Vantis Vascular are making waves in IVL, too.
The current approaches for clearing calcified arterial blockages include cutting balloons and atherectomy technology. IVL is designed to fracture the calcium within the artery wall. This potentially allows for vessel expansion and better stent placement. Abbott’s investigational system utilizes high-energy sound pressure waves to treat calcium blockages prior to placing a stent to achieve this.
“To everyone involved in reaching this milestone— thank you,” wrote Tyler. “Your leadership and dedication reflect the best of Abbott and help achieve our purpose of advancing healthcare for people with cardiovascular disease.”
