Summary
Abbott commences its coronary IVL system trial after receiving FDA approval, aiming to challenge rivals Boston Scientific and Johnson & Johnson in the expanding IVL market. The trial will assess the system’s efficacy in treating severe calcification in coronary arteries before stent implantation. This move follows Abbott’s recent setback with its orbital atherectomy system trial and highlights their determination to innovate in the cardiovascular treatment field.
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** Main Story**
Abbott Laboratories has initiated a U.S. clinical trial for its novel coronary intravascular lithotripsy (IVL) system after securing approval from the Food and Drug Administration (FDA). This trial, known as TECTONIC, signifies Abbott’s entry into the burgeoning IVL market, currently dominated by Johnson & Johnson and Boston Scientific, following their respective acquisitions of Shockwave Medical and Bolt Medical. The TECTONIC trial will involve 335 participants across 47 U.S. sites. Researchers will evaluate the system’s effectiveness in treating severe calcification in coronary arteries before stenting.
Abbott’s IVL System: A Potential Game-Changer?
Abbott is positioning its IVL system as a potentially superior alternative to existing treatments like cutting balloons and atherectomy technology. It uses high-energy sound pressure waves to fragment calcified blockages within the artery walls, facilitating vessel expansion and optimal stent placement. While the company hasn’t released specific details about its system’s unique features, it claims to address challenges posed by current IVL systems. This pursuit of innovation comes after a recent setback for Abbott, where their Diamondback 360 orbital atherectomy system failed to demonstrate superiority over balloon angioplasty in treating calcified lesions.
The IVL Market Landscape: A Competitive Arena
Abbott’s pursuit of its IVL system is especially notable given the rapid consolidation of the IVL market in recent years. Johnson & Johnson’s acquisition of Shockwave Medical for a record-breaking \$13.1 billion in 2024 gave it significant market share. Boston Scientific further solidified the competitive landscape with its $664 million acquisition of Bolt Medical in January 2025. These strategic moves underscore the growing value and potential of the IVL market, which experts predict will exceed $2 billion by 2034. Johnson & Johnson, with its established Shockwave technology, asserts a considerable lead over competitors. However, the entry of Abbott, along with other emerging companies like Amplitude Vascular Systems and Elixir Medical, suggests the IVL market will likely stay dynamic and competitive.
Significance and Potential Impact
The TECTONIC trial holds significant promise for advancing coronary artery disease (CAD) treatment. CAD affects approximately one in 20 American adults and remains a leading cause of death in the country. By facilitating better stent placement, Abbott’s IVL system could improve outcomes for patients with severe calcification, a condition that often complicates traditional interventions. The trial also marks a critical step for Abbott in strengthening its vascular portfolio after the previous trial setback. It reflects the company’s dedication to innovating and providing physicians with advanced tools for treating cardiovascular diseases. While the trial’s timeline and specific endpoints remain undisclosed, its outcome will undoubtedly shape the future trajectory of the IVL market. The success of Abbott’s IVL system could provide a valuable alternative for patients and further stimulate innovation in the field. It also reinforces the broader trend of technological advancement in medical devices, offering new hope for improved patient care and outcomes. As the trial progresses, healthcare professionals and industry observers will be closely watching its results and the potential impact on the rapidly evolving landscape of cardiovascular treatment.
Given Abbott’s previous setback with atherectomy, what specific design features or technological advancements are incorporated in their IVL system to address the challenges encountered in the prior trial and ensure improved efficacy in treating calcified lesions?
That’s a great question! While Abbott hasn’t publicly detailed specific design improvements, they are highlighting how IVL differs fundamentally from atherectomy. The use of sound waves, instead of mechanical cutting, may be a key factor in addressing the prior challenges and improving efficacy in calcified lesions. The TECTONIC trial results should provide more clarity!
Editor: MedTechNews.Uk
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The predicted growth of the IVL market to $2 billion by 2034 is impressive. How might the entry of new players like Abbott, alongside established companies, impact pricing strategies and accessibility of this technology for patients?