Intravascular lithotripsy (IVL), a method for breaking up calcified lesions in blood vessels, is gaining momentum as clinical trials progress rapidly. This technology, which uses sonic waves generated via fluid vaporization in an expanding balloon, gained prominence following Johnson & Johnson's acquisition of Shockwave Medical for $13.1 billion.
Amplitude Vascular Systems (AVS)
AVS is currently conducting a pivotal trial, named POWER-PAD-II, for its IVL system, Pulse IVL, after securing an investigational device exemption (IDE) from the FDA in June 2024. The study aims to evaluate the safety and efficacy of the AVS device in 120 patients diagnosed with peripheral artery disease (PAD). This trial follows AVS's POWER-PAD-I study (NCT05192473), which showed positive efficacy in patients with calcific femoropopliteal arteries. Unlike Shockwave’s bubble pulsatile effect, AVS uses CO₂ with a specialized diaphragm and amplifier to generate pulsatile energy waves.
Elixir Medical
Elixir Medical announced positive data from the PINNACLE I clinical trial in May 2024, assessing the safety and effectiveness of its catheter system. The trial results, presented at EuroPCR 2024, demonstrated that the device, LithiX Hertz, achieved a 98% clinical success rate and a 100% angiographic success rate in achieving optimal stent expansion. The clinical trial included 60 patients with calcified lesions across Belgium and the Netherlands.
Elixir’s transcatheter device utilizes multiple metal hemispheres to create focal stress points on the lesion via a balloon. By 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, minimizing vessel injury.
FastWave Medical
FastWave Medical announced positive results from a first-in-human study using its IVL technology in May 2024. The 30-day results came 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 stating that the early results could pave the way for a pivotal trial in the US.
Bolt Medical
Bolt Medical is in the pivotal trial stage, having completed enrollment in April 2024. The company is developing an IVL laser-based platform for treating PAD. The prospective, single-arm trial assessed the safety and efficacy of the Bolt IVL system in 95 enrolled patients across 11 centers in Europe. 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.
