Abbott makes IVL move as FDA approves new clinical trial
Abbott has received an investigational device exemption from the U.S. Food and Drug Administration (FDA) for a new clinical trial evaluating the safety and effectiveness of using its Coronary Intravascular Lithotripsy (IVL) System to treat severe calcification in patients with coronary artery disease (CAD).
According to Abbott, the TECTONIC CAD IVL Trial will enroll up to 335 patients throughout the United States. All patients will be treated with Abbott’s investigational coronary IVL technology, which uses high-energy sound pressure waves, prior to stenting.
“Through our expansive portfolio of treatment offerings, we aim to make interventions safer and more effective for people who need them most,” Jennifer Jones-McMeans, PhD, divisional vice president of global clinical affairs for Abbott's vascular business, said in a statement. “Now, by working with physicians to evaluate Abbott's Coronary IVL System, we are exploring the next generation of calcium modification technology, advancing our portfolio of treatments for coronary artery disease.”
“For people living with coronary artery disease, severe calcification can make treatment more challenging, often limiting the effectiveness of standard interventions like angioplasty or stenting,” added cardiologist Eric Secemsky, MD, co-principal investigator of the new trial and director of vascular intervention at the CardioVascular Institute at Beth Israel Deaconess Medical Center. “The TECTONIC CAD IVL trial will evaluate a possible new treatment option to prepare the vessel prior to stenting and optimize stent placement.”
IVL remains a top priority among medtech companies
IVL is one of the most in-demand technologies in all of healthcare. Johnson & Johnson acquired Shockwave Medical, the company that first started developing IVL in 2009, for $13 billion in 2024. Several other major vendors were rumored to be interested in acquiring Shockwave Medical at the time.
Boston Scientific, meanwhile, officially entered the IVL discussion in early 2025 when it agreed to acquire Bolt Medical for up to $664 million.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.