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J&J Explores New Artery Treatment
26 Jun
Summary
- J&J initiates clinical trials for a new carotid artery device.
- The investigational device aims to treat calcified arteries before stenting.
- The SKYWARD program will evaluate safety and effectiveness of the IVL system.
Johnson & Johnson has launched its SKYWARD investigational device exemption (IDE) clinical program to evaluate the Shockwave SkyRunner Carotid intravascular lithotripsy (IVL) system. This initiative focuses on treating calcified carotid arteries before stenting.
The first participant was enrolled at McLaren Bay Region Hospital in Bay City, Michigan. Carotid artery disease, a significant cause of strokes, involves plaque buildup in the arteries supplying the brain.
The SKYWARD program comprises two prospective, multi-center, single-arm IDE studies. These studies will examine the safety and effectiveness of the SkyRunner Carotid IVL system in patients at heightened risk from carotid endarterectomy. The system is intended for use before stenting via standard transcarotid or transfemoral techniques.
Up to 320 subjects are expected across both studies, with approximately 50 US sites participating. Long-term follow-up is planned for up to five years. National principal investigators include Drs William Gray, Nicolas Mouawad, Peter Schneider, and Peter Soukas.
The SkyRunner device is purpose-built for the carotid artery, featuring rapid exchange capability and tailored sizing. This innovation, driven by physician feedback, aims to provide a first-of-its-kind platform for calcific carotid disease, ultimately advancing patient outcomes.
