Johnson & Johnson Launches Fifth-Generation Shockwave C2 Aero Coronary IVL Catheter Globally

Pulse frequency doubled, treatment time reduced by 24%

C2 Aero increases the pulse frequency from 1Hz to 2Hz, delivering 10 pulses within 5 seconds. Balloon repressurization time is reduced by 50%, and overall treatment time is shortened by 24%. The emitter position is moved forward by 1mm to optimize energy distribution; the balloon retraction is more compact for precise adjustment.

Flexible Shaft + Hydrophilic Coating

The redesigned shaft, tapered tip, and new hydrophilic coating enhance the catheter's ability to navigate tortuous and narrow arteries, reducing reliance on auxiliary devices.

New Material Balloon, Achieving Bidirectional Positioning

After balloon inflation, it can retract more compactly and be repositioned bidirectionally within the coronary artery, facilitating the management of multiple tandem calcified lesions.

138cm Long Catheter + 240 Shockwaves, Wider Coverage

Working length of 138cm, compatible with 0.014-inch guidewire and 6F guiding catheter, capable of delivering up to 240 shockwave emissions, sufficient for treating long segmental diffuse calcified lesions.

Coronary calcification is one of the most challenging lesion types in percutaneous coronary intervention (PCI).

Shockwave IVL technology originates fromUrology Renal Calculi Shockwave Lithotripsy, the principle is throughThe balloon-mounted emitter generates ultrasonic pressure waves that penetrate soft tissue and selectively fragment calcified plaques within the vascular wall, preserving the integrity of the intima and media.Unlike the high-pressure squeezing of non-compliant balloons and the mechanical abrasion of rotational atherectomy, the acoustic pressure waves generated by IVL can act on deep calcium deposits, creating micro-fractures in the calcium without damaging the vessel wall, thereby creating lumen conditions for subsequent stent expansion. C2 Aero continues this mechanism.Each catheter is equipped with two emitters, capable of delivering up to 120 pulses and generating up to 240 shockwaves.

Clinical data of C2 Aero was presented at the late-breaking clinical trials session of the Cardiovascular Research Technologies (CRT) 2026 conference in the United States and simultaneously published in JACC: Cardiovascular Interventions.

To validate the efficacy and safety of the new platform, Shockwave Medical conducted the multicenter clinical trial Disrupt CAD DUO IDE trial.

• Study Scale and Patient Characteristics: The multicenter IDE trial (Disrupt CAD DUO) enrolled a total of145 casesPatient, Average Age70.5 years old.30% with diabetes, average lesion length 27.7mm, calcification length 39.6mm, belonging to a typical complex high-risk population.

• Surgical Success Rate: The proportion of successful surgeries without major adverse cardiovascular events (MACE) during hospitalization reached98.6%。

• Postoperative Safety: No MACE within 30 days postoperatively97.9%。

• Operational Efficiency: Reduced Balloon Repressurization Time50%，Overall treatment time shortened24%。

• Risk of Arrhythmia: IVL-Induced VentricularCapture incidence rate is approximately 66%,However, no clinically significant hypotension or malignant arrhythmia events were observed in the study.

The research team specifically pointed out that, although the incidence of ventricular capture increased slightly after the frequency was raised (occurring in approximately 66% of procedures),No clinically significant hypotension or malignant arrhythmia events were observed.Moreover, there was no significant difference in the total number of pulses delivered by the operator between procedures with and without ventricular capture, indicating that this phenomenon did not limit the normal implementation of IVL therapy.

In addition to the Disrupt CAD DUO IDE trial, C2 Aero'sVISION Extension StudySimilarly provided valuable real-world data. The study included a total of 105 patients from six centers in the United States, with an average age of 69.4 years, 37.1% female, 40% with comorbid diabetes, 31.4% with a history of heart failure, and 44.8% with multi-vessel disease. The cohort exhibited high risk and severe calcification. The key results showed:

• Surgical Success Rate98.1%（103/105）

• In-hospital MACE rate 4.8%, 30-day MACE rate 2.4%

• Only 1 case of slow flow, 1 case of no reflow, and 0 cases of perforation.

• Serious adverse events occurred in the elderly and diabetic populations and were unrelated to the study device.

• 97.1% (101/105) completed IVL pulse treatment within 5.0 minutes.

Researchers believe that the VISION extension study confirmed the safety and effectiveness of C2 Aero in real-world complex high-risk patients, demonstrating excellent performance in operational efficiency and clinical safety.

The IVL track is undergoing a transformation from "one dominant player" to "multiple contenders competing."

• Johnson & Johnson (J&J) is the absolute leader in the IVL market. In the first quarter of 2026, Shockwave Medical contributed $305 million in sales to Johnson & Johnson, representing an 18.5% year-over-year increase.

• Boston Scientific: Acquired Bolt Medical in 2025. Its Seismiq IVL System has received FDA approval for use in above-the-knee peripheral artery disease, with below-the-knee and coronary indications currently in progress.

• Stryker: Announced the acquisition of Amplitude Vascular Systems (AVS) in April 2026. Its Pulse IVL utilizes pneumatic hydraulic technology, with plans to submit a 510(k) application in 2026.

• Abbott: Received FDA IDE approval in March 2025 to initiate the pivotal TECTONIC CAD IVL trial, involving 335 patients across 47 centers, with an expected completion in 2028.

• Other participants: Elixir Medical (Mechanical IVL, already listed), FastWave Medical (raised $19 million)

C2 Aero to Make Its First Public European Debut at EuroPCR 2026 in Paris from May 19-22, 2026. Johnson & Johnson will demonstrate the operation process of C2 Aero live at their booth and provide clinical data interpretation and case sharing. This is an unmissable opportunity for interventional cardiologists eager to learn about the latest advancements in IVL technology.