Abbott announced that the FDA has approved an investigational device exemption (IDE) for its Coronary Intravascular Lithotripsy (IVL) System to evaluate the treatment of severe calcification in coronary arteries prior to stenting. The TECTONIC Coronary Artery Disease (CAD) Intravascular Lithotripsy (IVL) clinical trial will enroll up to 335 people in 47 sites in the U.S.
IVL is a newer treatment for calcified coronary arteries that treats blockages by fracturing the calcium within the artery wall, potentially allowing for vessel expansion and better stent placement. Abbott's investigational Coronary IVL System uses high-energy sound pressure waves to treat calcium blockages prior to placing a stent.
"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," said Eric Secemsky, M.D., director of vascular intervention at the CardioVascular Institute, Beth Israel Deaconess Medical Center in Boston, MA and co-principal investigator for the TECTONIC Coronary Artery Disease (CAD) Intravascular Lithotripsy (IVL) trial. "The TECTONIC Coronary Artery Disease (CAD) Intravascular Lithotripsy (IVL) trial will evaluate a possible new treatment option to prepare the vessel prior to stenting and optimize stent placement."
Abbott's investigational Coronary IVL technology builds upon the company's existing vascular portfolio and is designed to address challenges of currently available IVL systems. Today, Abbott's portfolio of treatment solutions includes optical coherence tomography (OCT) imaging technology, which assesses coronary arteries and detects calcium buildup to help physicians identify the arteries that could benefit from plaque modification. The company's advanced technologies are designed to ensure complete vascular support including artery assessment, preparation, and treatment.
"Abbott is a leader in treating coronary artery disease, offering the best diagnostics and therapeutic options for calcium detection and treatment at every stage. Through our expansive portfolio of treatment offerings, we aim to make interventions safer and more effective for people who need them most," said Jennifer Jones-McMeans, Ph.D., divisional vice president of global clinical affairs at Abbott's vascular business. "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."
Abbott's Coronary Intravascular Lithotripsy (IVL) system is an investigational device and not commercially available.
