IVL competition heats up as Boston Scientific enters US market
Boston Scientific announced on social media that the first U.S. commercial cases using its new Seismiq intravascular lithotripsy (IVL) system took place in January, marking the availability of a new system for use in above-the-knee peripheral artery disease (PAD) lesions.
"As we begin the limited market release of Seismiq, our focus remains on learning, execution and ultimately expanding access to this therapy," Catherine Jennings, president of Boston Scientific peripheral vascular said on LinkedIn.
The system uses laser-generated acoustic pressure waves inside a balloon catheter to fracture both superficial and deep calcium within the wall of the artery while preserving surrounding soft tissue.
Boston Scientific purchased Bolt Medical in January 2025 to acquire its IVL technology. The Bolt IVL system then received a new name and secured U.S. Food and Drug Administration (FDA) approval in early 2025 based on data from the RESTORE ATK clinical trial.
Boston Scientific sees Seismiq as a next-generation IVL system. The device offers consistent acoustic output across all emitter stations on the balloon and real-time feedback on the therapy's impact. It does not require sterile bagging of the handle.
Shockwave says it will remain a leader in the IVL market
Shockwave Medical, a part of Johnson & Johnson MedTech, has dominated the IVL market for many years now. The company's chief medical officier, Nick West, MD, told Cardiovascular Business in a recent interview he is not concerned about the coming competition from several vendors that have IVL systems in trials or development. He said Shockwave has a decade lead on competitors in terms of clinical usage and clinical data.
Shockwave offers FDA-cleared IVL for both PAD and the coronary arteries. According to West, the company is working to expand to additional anatomies and indications.
"Now we're north of 10% penetration in the coronary procedures,” West explained, noting that this figure does not include peripheral use. He added that Shockwave also recently marked a major milestone, with 1 million patients treated, calling it “a hell of a milestone for eight years in use.”
Other IVL competitors currently in clinical trials
Other potential competitors with IVL systems in development include Abbott Vascular, Philips Healthcare and start ups FastWave and Amplitude Vascular Systems Medical.
Abbott purchased Cardiovascular Systems Inc. (CSI) in 2023, which included an IVL system CSI already had in development. The company initiated its TECTONIC CAD IVL IDE Study in 2025. It will test the Abbott Coronary IVL System to treat severely calcified, stenotic de novo coronary arteries prior to stenting in 335 subjects at up to 55 sites in the U.S. The system uses high-energy sound pressure waves to bust calcium. The trial's estimated completion date in June 2028.
Philips Healthcare, meanwhile, started enrollment in the U.S. THOR IDE clinical trial in the fall of 2024 for its combined laser atherectomy and intravascular lithotripsy catheter to treat PAD. The company expects trial completion by the end of 2027.
FastWave, meanwhile, plans to begin a U.S. investigational device exemption (IDE) pivotal trial for its Artero peripheral electric IVL (E-IVL) system for PAD.
Amplitude Vascular Systems (AVS) Pulse is also working to enter the U.S. market. The company's Pulse IVL System is currently enrolling 120 patients at 20 clinical sites in the POWER PAD 2 study, which is expected to be completed by March of 2026.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]