Abbott Initiates New Intravascular Lithotripsy Clinical Trial to Improve Outcomes in Patients with Coronary Artery Disease

Rhea-AI Summary

Abbott (NYSE: ABT) has received FDA approval for an investigational device exemption (IDE) to evaluate its Coronary Intravascular Lithotripsy (IVL) System in treating severe calcification in coronary arteries before stenting. The TECTONIC trial will enroll up to 335 people across 47 U.S. sites.

The technology uses high-energy sound pressure waves to fracture calcium within artery walls, potentially improving vessel expansion and stent placement. This development addresses Coronary Artery Disease (CAD), which affects over 20 million U.S. adults and is America's leading cause of death.

Abbott's IVL system complements their existing vascular portfolio, which includes optical coherence tomography (OCT) imaging technology for calcium detection. The system aims to overcome limitations of current treatment approaches like cutting balloons and atherectomy technology.

Positive

• FDA approval received for investigational device exemption (IDE)
• Large-scale clinical trial with 335 participants across 47 sites
• Addresses major market with over 20 million affected U.S. adults
• Complements existing product portfolio in vascular treatments

Negative

• Product is still investigational and not commercially available
• Faces competition from existing treatment methods (cutting balloons and atherectomy)
• Success of the technology yet to be proven in clinical trials

Insights

Medical Device Industry Analyst

Abbott's FDA approval for an investigational device exemption (IDE) for its Coronary Intravascular Lithotripsy (IVL) System represents a strategic pipeline advancement in the company's vascular portfolio. This positions Abbott to potentially compete in the calcium-modification segment of coronary interventions, currently dominated by specialized players like Shockwave Medical.

The TECTONIC trial targeting 335 patients across 47 US sites demonstrates Abbott's commitment to expanding its comprehensive CAD treatment ecosystem. The company is strategically building an integrated solution combining diagnostic imaging (OCT for calcium detection) with therapeutic options (potential future IVL technology).

This move aligns with Abbott's long-term strategy of offering complete vascular support through the entire patient journey: assessment, preparation, and treatment. By addressing the challenges of current IVL systems, Abbott aims to differentiate its offering in a segment with significant clinical need, considering over 20 million US adults affected by CAD.

While this development strengthens Abbott's pipeline, investors should note this represents early clinical-stage technology that likely remains years from commercialization and revenue contribution. The potential market opportunity is substantial, but material financial impact depends on successful trial outcomes, regulatory approval timelines, and eventual market adoption.

Interventional Cardiologist

The clinical significance of Abbott's IVL technology development stems from the persistent challenge of coronary calcification, which complicates approximately 30% of percutaneous coronary interventions. Calcium modification before stenting remains a critical unmet need despite existing options like rotational atherectomy and cutting balloons.

Intravascular lithotripsy represents an emerging approach using sound pressure waves to fracture calcium deposits while potentially minimizing vessel trauma compared to mechanical atherectomy. The technology's main advantage is its ability to modify both superficial and deep calcium deposits while maintaining a relatively simple procedural technique.

Abbott's entry into this space is notable given their established presence in coronary interventions and complementary diagnostic capabilities through OCT imaging. The integration of calcium assessment and treatment could potentially streamline procedural workflows and improve outcomes.

The TECTONIC trial will provide critical data on safety endpoints and procedural success rates compared to existing calcium modification approaches. Key performance indicators will likely include successful stent delivery, minimal vessel injury, and optimal stent expansion in severely calcified lesions. While promising, the technology must demonstrate clear advantages over existing solutions to achieve widespread adoption in clinical practice.

• Coronary Artery Disease (CAD) is the most common heart disease and most frequent cause of death in the U.S., with over 20 million adults affected by this condition
• Abbott's investigational Coronary Intravascular Lithotripsy (IVL) System offers a new potential treatment by using sound pressure waves to treat arterial calcium blockages
• Abbott offers a comprehensive vascular portfolio of technologies designed to assess, treat and manage calcium buildup in coronary arteries

ABBOTT PARK, Ill., March 24, 2025 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (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.

Coronary Artery Disease (CAD) is the most common heart disease in the U.S., with more than 20 million adults impacted by the condition.^1,2 CAD also remains the single most frequent cause of death in America.³ CAD develops when plaque builds up in the vessel blocking blood flow and oxygen supply to the heart requiring vessel interventions.

Currently, physicians often use several therapy approaches to clear calcified arterial blockages, including cutting balloons and atherectomy technology. 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.

About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com and on LinkedIn, Facebook, Instagram, X and YouTube.

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/

 

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SOURCE Abbott

FAQ

What is the size and scope of Abbott's TECTONIC CAD trial for the new IVL System?

The trial will enroll up to 335 participants across 47 U.S. sites to evaluate the IVL System's effectiveness in treating severe coronary artery calcification.

How does Abbott's new Intravascular Lithotripsy (IVL) System treat coronary artery calcification?

The system uses high-energy sound pressure waves to fracture calcium deposits within artery walls, aiming to facilitate better vessel expansion and stent placement.

What market size is Abbott targeting with its new IVL System for CAD?

The system targets the Coronary Artery Disease market, which affects over 20 million adults in the U.S. and is the country's leading cause of death.

How does Abbott's IVL System integrate with their existing coronary treatment portfolio?

It complements Abbott's OCT imaging technology for calcium detection and extends their comprehensive vascular treatment solutions for artery assessment, preparation, and treatment.