By: Jennifer Jones-McMeans, PhD , Divisional Vice President of Global Clinical Affairs at Abbott
Sponsored by Abbott
Severe calcification is one of the complex challenges faced by interventional cardiologists. Intravascular Lithotripsy (IVL) is emerging as a promising treatment option for Coronary Artery Disease (CAD).
- This condition affects over 20 million adults in the U.S.[1,2]and remains a leading cause of death in America.[3]
- CAD occurs when plaque builds up in the vessel, blocking blood flow and oxygen supply to the heart, requiring vessel interventions.
Traditional therapies for calcified arterial blockages include cutting balloons and atherectomy. However, the introduction of advanced technology, such as Abbott’s IVL, offers an alternative approach, potentially allowing for better vessel expansion and stent placement.
- Kathleen Kearney, M.D., Associate Professor, University of Washington Medical Center, Division of Cardiology, underscores the need for new treatment options: “With increasing complexity of coronary disease presenting for PCI, an expansion of solutions are needed, especially for severe calcification.”[4]
Abbott’s investigational Coronary IVL System is designed to create high-energy acoustic pressure waves to treat calcium blockages prior to placing a stent.
- It would supplement the company’s vascular product portfolio including Ultreon 2.0, Abbott’s advanced imaging technology to ensure physicians have comprehensive vascular support for artery assessment, preparation, and treatment.
Fast Facts:
- In March, the U.S. Food and Drug Administration (FDA) approved an investigational device exemption (IDE) for Abbott’s new IVL System to evaluate the treatment of severe calcification in coronary arteries prior to stenting.
- Abbott’s TECTONIC CAD IVL clinical trial plans to enroll 335 people across 55 U.S. sites The first procedure was completed on April 1st , 2025, by Dr. Bassem Chehab at Ascension Via Christi St. Francis Hospital.
The Takeaway
IVL is a newer treatment for calcified coronary arteries, and Abbott’s Coronary IVL System has the potential to treat severe calcification prior to stenting. Learn more about Abbott’s TECTONIC CAD IVL clinical trial by clicking here.
References:
1. Nowbar, A.N., et al., Mortality From Ischemic Heart Disease. Circ Cardiovasc Qual Outcomes, 2019. 12(6): p. e005375.
2. Tsao, C.W., et al., Heart Disease and Stroke Statistics-2023 Update: A Report From the American Heart Association. Circulation, 2023. 147(8): p. e93-e621.
3. Brown JC, Gerhardt TE, Kwon E. Risk factors for coronary artery disease. PubMed. Published January 23, 2023. https://www.ncbi.nlm.nih.gov/books/NBK554410/
4. Hennessey B, Pareek N, Macaya F, Yeoh J, Shlofmitz E, Gonzalo N, Hill J, Escaned J. Contemporary percutaneous management of coronary calcification: current status and future directions. Open Heart. 2023 Feb;10(1):e002182. doi: 10.1136/openhrt-2022-002182. PMID: 36796870; PMCID: PMC9936324.
