The market for intravascular lithotripsy (IVL), a procedure utilised to break calcified lesions in blood vessels, might be at a relatively immature stage. However, clinical trials evaluating the approach are advancing at a rapid speed.
The technology, which involves generating sonic waves via fluid vaporisation in an expanding balloon, was thrust into the spotlight when one of the pioneers in the industry – Shockwave Medical – was acquired by Johnson & Johnson (J&J) in a $13.1bn deal.
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Earlier this week, Shockwave rolled out a new IVL catheter in the US for patients living with certain types of peripheral artery disease (PAD). This strengthened Shockwave’s grasp on the market, which started back when the company was the first to receive approval for an IVL catheter in 2021.
IVL has legs beyond Shockwave’s technology, a review paper said that the procedure is a safe and effective strategy for lesion preparation in severely calcified lesions before stent implantation in coronary arteries.
Amid IVL’s advancement, Clinical Trials Arena looks at other companies with candidate products and how their clinical development journeys are panning out.
Amplitude Vascular Systems (AVS)
AVS is conducting a pivotal trial for its IVL system – named Pulse IVL – after the company won an investigational device exemption (IDE) from the FDA in June 2024. The POWER-PAD-II clinical study will evaluate the safety and efficacy of AVS’ device in 120 patients with PAD.
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By GlobalDataThe POWER-PAD-II clinical study follows the company’s POWER-PAD-I study (NCT05192473), which demonstrated positive efficacy in patients with calcific femoropopliteal arteries. Unlike Shockwave’s bubble pulsatile effect, AVS uses CO₂ with a specialised diaphragm and amplifier to generate pulsatile energy waves.
Elixir Medical
Elixir reported positive data from the PINNACLE I clinical trial evaluating the safety and effectiveness of its catheter system in May 2024. The results, shared at EuroPCR 2024, demonstrated the device – named LithiX Hertz – led to a 98% clinical success rate and 100% angiographic success in achieving optimal stent expansion. The clinical trial enrolled 60 patients with calcified lesions across Belgium and the Netherlands.
Elixir’s transcatheter device uses multiple metal hemispheres that create points of focal stress on the lesion via a balloon. Employing the physics principle of Hertz Contact Stress, fragmentation is achieved after force is applied. Elixir states that non-calcified segments of the lesion are mostly unaffected, minimising vessel injury.
FastWave Medical
FastWave announced positive results from a first-in-human study using its IVL technology in May 2024. The 30-day results were from the company’s prospective, single-arm study to assess the safety and feasibility of the FastWave IVL system in patients with PAD affecting the superficial femoral artery and popliteal artery with calcified lesions.
FastWave reported that eight patients were successfully treated, with CEO Scott Nelson saying the early results could pave the way for a pivotal trial in the US.
Bolt Medical
Bolt Medical is one of the companies at the pivotal trial stage – completing enrolment in April 2024. The company is developing an IVL laser-based platform for the treatment of PAD.
The prospective, single-arm trial assessed the safety and efficacy of the Bolt IVL system in 95 enrolled patients across 11 centres in Europe.
Bolt said data from the study, named RESTORE ATK, will be presented later this year and will be used to support FDA 510k and CE Mark regulatory submissions.
