Abbott Enters IVL Market as Competition Heats Up in Cardiovascular Device Space

Abbott has received approval from the U.S. Food and Drug Administration (FDA) to begin a clinical trial for its intravascular lithotripsy (IVL) system, designed to treat severe calcification in coronary arteries. This move comes amid increased competition and recent acquisitions in the IVL market, signaling a shift in the landscape of cardiovascular treatments.

Abbott's IVL System Enters Clinical Trials

Abbott announced on Monday that it has been granted FDA approval to initiate a U.S. clinical trial for its IVL system. The device uses sound pressure waves to break up calcium deposits that obstruct blood flow in coronary arteries. According to Abbott, their system is engineered to address challenges faced by currently available IVL technologies.

The trial will enroll up to 335 participants across 47 U.S. sites, focusing on the treatment of severe calcification in coronary arteries prior to stenting. Abbott aims to position its IVL system as a superior alternative to existing methods such as cutting balloons and atherectomy technology for clearing calcified arterial blockages.

Robert Ford, Abbott's CEO, had previously expressed high priority for the IVL program following the company's acquisition of Cardiovascular Systems Inc. (CSI) for $890 million in 2023. Ford anticipates Abbott's entry into the IVL market by 2027, though specific timelines and endpoints for the current trial have not been disclosed.

Market Dynamics and Recent Acquisitions

The IVL market has seen significant consolidation in recent months, with major players making strategic moves to strengthen their positions:

• Johnson & Johnson acquired Shockwave Medical for $13.1 billion in 2024.
• Boston Scientific agreed to purchase Bolt Medical for up to $664 million in January 2025.

These acquisitions have reshaped the competitive landscape, with J&J claiming a substantial lead in the IVL space. Tim Schmid, J&J's worldwide chairman of medtech, stated at a recent conference that the Shockwave portfolio gives them a "five- to seven-year head start on any competitors in the IVL space."

Bolt Medical, soon to be part of Boston Scientific, completed pivotal trials of its IVL system in late 2024 and plans to use the data for regulatory filings in the U.S. and Europe.

Abbott's entry into IVL trials follows a setback in another area of its cardiovascular portfolio. A recent study found that orbital atherectomy with Abbott's Diamondback 360 device, acquired in the CSI buyout, showed no superior efficacy in treating severely calcified lesions compared to conventional balloon angioplasty.

As the IVL market continues to evolve, Abbott's clinical trial marks a significant step in the company's efforts to compete in this rapidly advancing field of cardiovascular treatment.