Spectrumedics Medical has obtained a CE mark for its coronary intravascular lithotripsy (IVL) system under the European Union’s Medical Device Regulation (EU MDR).
The Singapore-based company’s Sonico-CX IVL system uses acoustic pressure waves to treat calcified coronary lesions. With the CE mark in hand, Spectrumedics will now focus on commercialising the system in Europe, having previously gained the relevant clearances to initiate commercial rollouts of its system in Latin America and the Asia Pacific (APAC) regions.
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Spectrumedics founder and CEO Dr Elynn Phang said: “This achievement marks a significant step in Spectrumedics’ mission to broaden global access to advanced IVL therapy. We look forward to collaborating with more physicians to deliver faster, safer, and more effective treatment to patients with complex calcification worldwide.”
The nascent IVL market
The IVL market remains in its infancy. Thrust into the spotlight when Johnson & Johnson (J&J) acquired Shockwave Medical in a $13.1bn deal in June 2024, the treatment is positioned as a minimally invasive advancement to treating calcified lesions with atherectomy, in which more invasive manual processes, such as rapidly rotating burrs, are used to remove arterial plaque.
Shockwave first launched its IVL system for treating peripheral arterial disease (PAD) in Europe in 2015 and became the first IVL system for PAD treatment to receive US Food and Drug Administration (FDA) approval in 2016. In 2021, the FDA granted an additional clearance for coronary artery disease (CAD) treatment.
Now under J&J’s ownership, Shockwave has remained the major player in the IVL space since its European introduction. Shockwave’s latest IVL product, the Javelin Peripheral IVL catheter, launched in Europe in September 2025. GlobalData analysts note that this latest development is liable to continue the advance of J&J’s IVL portfolio growth, given that competition in the market remains sparse.
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By GlobalDataOther big players in the medtech industry are also eyeing the IVL space. Boston Scientific helped establish Bolt Medical in 2019 and has held a 26% stake in the company since. Following promising results for the company’s IVL technology, Boston agreed to acquire the remaining 74% stake in a deal worth up to $664m in January 2025. Bolt’s system received FDA clearance in March 2025, but is not yet commercially available.
Abbott is also looking to enter the space, having received an investigational device exemption (IDE) from the FDA in March 2025 to evaluate its coronary IVL system in a clinical trial.
Meanwhile, Elixir Medical initiated the European launch of its LithiX Hertz Contact (HC) IVL system in April 2025, outpacing Boston’s Bolt Medical. The company has not currently outlined plans for a US market entry.
According to GlobalData analysis, the IVL space, a part of the atherectomy device sector, is forecast to grow to over $2bn in value by 2034.
