Shockwave Javelin IVL catheter shows positive results in pivotal FORWARD CAD study

Johnson & Johnson has reported positive 30-day results from the pivotal FORWARD CAD investigational device exemption study evaluating the Shockwave Javelin Coronary Intravascular Lithotripsy catheter.

The investigational device is designed to treat severely stenosed, calcified coronary artery lesions that are difficult to cross before stent placement.

Results were presented at the 2026 Transcatheter Cardiovascular Therapeutics congress in San Diego.

In the 158-patient pivotal cohort, the study exceeded its prespecified performance goals for both safety and effectiveness.

The primary effectiveness endpoint was achieved in 93.6% of patients.

This endpoint measured successful lesion crossing using Shockwave Javelin without serious angiographic complications at final imaging.

The primary safety endpoint showed that 93.4% of patients remained free from major adverse cardiovascular events through 30 days.

Major adverse cardiovascular events were defined as a composite of cardiac death, myocardial infarction or target vessel revascularisation.

The study population included patients with particularly complex calcified coronary disease.

Around 96% of treated lesions were moderately or severely calcified, while the average diameter stenosis was 81%.

Chronic total occlusions were present in 20% of lesions.

Despite this level of disease complexity, serious angiographic complications at final imaging occurred in 1.3% of patients.

Robert Yeh, MD, MBA, Global Co-Principal Investigator of FORWARD CAD and Section Chief of Interventional Cardiology at Beth Israel Deaconess Medical Center, said the ability to cross heavily calcified lesions remains an important limitation in coronary intervention.

He said the findings suggest that the device may help create a treatment pathway for patients whose lesions are difficult to manage using conventional balloon-based calcium modification techniques.

James Spratt, MD, Global Co-Principal Investigator of the study at St. George’s University NHS Trust, said the results suggest that difficult-to-cross lesions can be treated successfully without compromising safety.

The FORWARD CAD study was a prospective, multicentre, single-arm trial conducted across 28 sites in the U.S. and U.K.

It enrolled patients with severely stenosed, de novo calcified coronary lesions defined by moderate to severe calcification on angiography.

Eligible lesions included those with more than 90% stenosis and a length below 40 mm, as well as chronic total occlusions meeting specified complexity criteria.

The Shockwave Javelin Coronary IVL platform uses a single distal emitter to generate ultrasonic acoustic pressure waves.

The system produces a spherical energy field extending beyond the catheter tip, which is designed to deliver lithotripsy closer to highly stenosed calcified lesions than balloon-based intravascular lithotripsy platforms.

The device remains investigational in the U.S.

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