Boston Scientific Enrolls First Patient in ELEGANCE Study for Seismiq Intravascular Lithotripsy System

ELEGANCE is a prospective registry study by Boston Scientific, which previously included the Ranger drug-coated balloon and Eluvia drug-eluting stent to evaluate real-world outcomes in peripheral artery disease.

The study has a requirement for population diversity: the proportion of female and minority patients in the enrolled group should each be no less than 40%. The addition of the Seismiq IVL cohort indicates that Boston Scientific is attempting to integrate IVL therapy into its existing peripheral intervention product portfolio, while simultaneously accumulating evidence for the combined application of multiple devices.

# Laser IVL vs. Arc Discharge IVL: The Head-to-Head Clash of Two Technical Routes

There are currently two main energy routes in the IVL field.

• Shockwave (J&J) series products are based on the principle of arc discharge, where copper wire generates discharge inside the balloon to produce acoustic pressure waves that break down calcification.

• Boston Scientific's Seismiq and FastWave Medical's Sola adopt the laser-driven approach, generating acoustic pressure waves by transmitting laser energy through optical fibers.

The core differentiating features of Seismiq include:Directional emitters visible, emitter sites with selective switching to achieve pulse savings, consistent acoustic output across all emitter sites, real-time feedback on treatment efficacy, and a fully sterile catheter design that eliminates the need for a sterile bag around the handle.

Published in May 2026Circulation: Cardiovascular InterventionsThe Seismiq 4CE Coronary Catheter First-in-Human Study (RESTORE FIH, 41 cases) showed that laser-fiber IVL was comparable to existing arc-discharge IVL in terms of safety and efficacy. Meanwhile, the authors notedFiber optics do not generate electromagnetic noise when there is no arc discharge, and the myocardial capture rate may be lower.——This potential advantage still needs to be validated with a larger sample.

In terms of Shockwave, the C2 Aero, globally launched by Johnson & Johnson on May 12, is its fifth-generation coronary IVL catheter, with a working length of 138cm and equipped with 2 emitters. A single catheter can deliver up to 120 pulses (240 shock waves). The key upgrade is the balloon's ability to rewrap (Balloon Rewrap), allowing for bidirectional repositioning and lesion re-crossing during the procedure, addressing the previous pain point of difficulty in readjusting the C2 catheter after deployment.

# IVL Track Competition Pattern: An Accelerated Race Driven by Giant Mergers and Acquisitions

From 2024 to present, the IVL sector has undergone intensive mergers and acquisitions.The global IVL market size is expected to grow from approximately USD 1.04 billion in 2025 to about USD 2.84 billion in 2032 (CAGR of approximately 15.5%)., the Asia-Pacific region has the fastest growth rate.

Stryker announced the acquisition of Amplitude Vascular Systems (AVS) in April 2026, with the transaction completed on May 7. AVS's Pulse IVL platform uses pulsed CO₂ gas to generate pressure waves at a frequency of approximately 15 times per second, without the need for traditional electrodes or transmitters, and delivers energy uniformly across the entire length of the balloon. The system has not yet received FDA approval and is currently in the IDE stage.

# China IVL Market: Domestic Production Has Achieved a "From 0 to 4" Breakthrough

The progress speed of China's IVL track is also worth noting.Shockwave IVL was introduced by Jian Shi Medical and received NMPA approval for marketing in May 2022., is the first IVL product in China.

But domestically produced ones are catching up very quickly:

• Huihe MedicalC-Wave^®The peripheral IVL system was approved by the NMPA in August 2023, becoming the first domestically produced IVL product to receive approval in China.

• Saihe MedicalThe coronary IVL system was approved in October 2023, forChina's First Domestically Produced Coronary IVL。

• Lepu MedicalThe coronary shockwave catheter was approved for marketing in January 2024 (the 3rd coronary IVL globally).

• Blue Sail BoyuanThe Soni Cracker™-CL was approved in May 2024, becoming the fourth domestically produced coronary IVL in China.

• Minimally Invasive MelodyThe coronary shockwave balloon has entered the NMPA Innovative Medical Device Special Review "Green Channel", MicroPort RotaPace's TomaHawk^®Integrated Coronary IVL System Receives China Market Approval in February 2024.

According to incomplete statistics,Nearly 10 IVL companies in China are currently under development, in clinical trials, or already registered.。

Notable Differences: Currently, all domestically approved IVL products in China are based on the arc discharge/hydraulic lithotripsy route. The laser IVL route represented by Boston Scientific's Seismiq and FastWave has no equivalent product entering the registration process in China. If laser IVL demonstrates clinical advantages such as a lower myocardial capture rate in large-scale trials, it may trigger a new round of technological iteration in China. However, under the centralized procurement policy environment, the likelihood of IVL, as a combination product of equipment + consumables, being included in national-level centralized procurement in the short term is relatively low—drawing from the experience of Fujian’s centralized procurement in the electrophysiology field, the volume-based procurement for equipment + consumables tends to be milder compared to pure consumable categories.

# Heart Future·Observation

The competition in the IVL track has shifted from "whether to enter" to the "how to differentiate" stage.Johnson & Johnson, with Shockwave's first-mover advantage over the past decade and an accumulation of evidence from more than 500 peer-reviewed publications, still maintains a deep moat of clinical trust in the short term.——Shockwave CMO Nick West publicly stated that competing products lag behind by at least a decade in terms of clinical data accumulation. However, the publication of Seismiq RESTORE FIH data, the balloon re-wrapping upgrade of C2 Aero, and FastWave entering the IDE phase all signal that the technological gap is narrowing—not because the追赶者 (pursuers) are improving, but because the technical paradigm defined by Shockwave itself has become the benchmark for追赶 (catching up).

The variable in the Chinese market is: When overseas giants compete around laser IVL, domestically produced arc discharge IVL has already formed a competitive landscape with multiple approved players.If the laser route proves to have clinical advantages, whether domestically-produced enterprises are capable of switching technological routes in the next generation of products will determine the long-term landscape of China's IVL sector.