Intravascular lithotripsy predictions from Amplitude Vascular Systems

An illustration of an AVS Pulse balloon catheter breaking up arterial calcification while expanding the blood vessel.

AVS designed its Pulse system to expand the artery while it breaks up the calcium to restore blood flow. [Illustration courtesy of AVS]

Johnson & Johnson’s $13 billion acquisition of Shockwave Medical was the biggest medtech deal of 2024, leaving no doubt as to the value of intravascular lithotripsy (IVL) technology for minimally invasive treatment of coronary artery disease (CAD) and peripheral artery disease (PAD).

But Shockwave’s not the only player in the IVL market, and challenger Amplitude Vascular Systems (AVS) has a big advantage from the design of its Pulse IVL system, AVS Executive Chair Mark Toland told Medical Design & Outsourcing in 2024.

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AVS VP of Business Development Angie Volk offered four predictions for the IVL market in 2025. Volk, like AVS Chief Operations Officer Sean Gilligan, spent decades at Boston Scientific before joining Boston-based AVS. (The following has been lightly edited for clarity and length.)

Amplitude Vascular Systems VP of Business Development Angie Volk [Photo courtesy of Amplitude Vascular Systems]
International expansion: “J&J’s last earnings report for Q3 2024 showed significant growth in outside-the-U.S. revenue versus prior quarters, from $43 million in Q1 2024 to $66 million in Q3 2024, jumping from 20% to 29% of global revenue distribution. Other regions are starting to realize the benefit in outcomes and various global reimbursement measures are catching up to the U.S.”
Expanded indications: “J&J recently gained formal approval for below-the-knee (BTK) lesions with their E8 device, enabling treatment of smaller and longer lower extremity disease. They also recently presented and published data from their Javelin device, which involved a forward-positioned emitter designed to treat occlusive disease.”
Reimbursement: “While there is currently a gap in outpatient coverage for coronary Shockwave usage, this is expected to be addressed intra-year 2025, perhaps with retrospective payment options.”
Competition: “While Shockwave has enjoyed ‘only’ status for several years, many other companies (both startups and large strategics) are making headway in their own IVL programs. This includes technology with similar electrical mechanism of action as Shockwave like FastWave Medical and Abbott, to those using laser modality like Bolt and Philips, to AVS, which achieves the same calcium modification but through hydraulic pressure peaks versus electrical. It will be interesting to see how hospitals decide how many IVL platforms they utilize in their practices and how they decide which one to use on which patient.”