J&J's Shockwave Medical Advances Lithotripsy Technology for Coronary Artery Disease

Johnson & Johnson MedTech's Shockwave Medical division is pushing the boundaries of intravascular lithotripsy, expanding its innovative technology from peripheral arteries to the coronary arteries. This move marks a significant step forward in treating calcified lesions in heart vessels, potentially offering new hope for patients with complex coronary artery disease.

Javelin System: From Legs to Heart

After successfully launching the Javelin system for peripheral artery disease in early March, Shockwave Medical is now setting its sights on the heart. The Javelin system, which uses sonic pressure waves to break down calcium deposits in blood vessels, is being adapted for use in coronary arteries.

The peripheral artery version of Javelin, FDA-cleared in September of the previous year, emits up to 120 pulses in a spherical energy field from its tip. This forward-facing design allows the device to get closer to calcium deposits compared to traditional balloon-based approaches, potentially improving its effectiveness in clearing blockages.

FORWARD CAD: Pivotal Study Underway

J&J has initiated a pivotal study named FORWARD CAD to evaluate a cardiac-focused version of the Javelin system. This single-arm study aims to assess the device as a first-line treatment for narrowed, calcified coronary vessels, preparing the way for stent placement.

The study plans to enroll up to 158 patients across the United States and the United Kingdom. Participants will include individuals with stable chest pain symptoms and those eligible for non-emergency cardiac procedures. The first patient has already been treated at St. Francis Hospital & Heart Center in Long Island, New York, marking the beginning of this important clinical investigation.

Implications for Coronary Artery Disease Treatment

If successful, the cardiac Javelin system could provide cardiologists with a new tool to tackle challenging calcified lesions in coronary arteries. This technology has the potential to improve outcomes for patients with complex coronary artery disease, who often face limited treatment options.

The expansion of Shockwave's lithotripsy technology from peripheral to coronary applications demonstrates the company's commitment to addressing unmet needs in cardiovascular care. As the FORWARD CAD study progresses, the medical community will be watching closely to see if this innovative approach can deliver on its promise in the critical area of heart health.