Abbott Wins FDA IDE Nod for Coronary IVL Trial

Abbott has received U.S. Food and Drug Administration (FDA) approval for an investigational device exemption (IDE) for its coronary intravascular lithotripsy (IVL) system to evaluate treatment of severe calcification in coronary arteries prior to stenting.

The TECTONIC Coronary Artery Disease (CAD) 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 in the artery wall. This potentially allows vessel expansion and better placement of stents. Abbotts investigational Coronary IVL system leverages high-energy sonic pressure waves to treat calcium blockages before placing a stent.

Eric Secemsky, MD, director of vascular intervention at the CardioVascular Institute, Beth Israel Deaconess Medical Center in Boston, and co-principal investigator for the TECTONIC Coronary Artery Disease (CAD) Intravascular Lithotripsy (IVL) trial said that severe calcification can make treatment more challenging for people with coronary artery disease, often limiting effectiveness of standard interventions like angioplasty or stenting.

“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,” Dr. Secemsky told the press.

The investigational Coronary IVL tech build on Abbott’s vascular portfolio and was designed to overcome challenges of current IVL systems. The company’s portfolio also includes optical coherence tomography (OCT) imaging, which assesses coronary arteries and detects calcium buildup so physicians can identify arteries that might benefit from plaque modification.

“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 VP 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.”