Johnson & Johnson (J&J) has initiated enrolment in its SKYWARD investigational device exemption (IDE) clinical programme to evaluate the Shockwave SkyRunner Carotid intravascular lithotripsy (IVL) system.
The initiative aims to treat calcified carotid arteries before stenting. The first participant was treated at McLaren Bay Region Hospital in Bay City, Michigan, US.
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Accounting for up to 30% of strokes, carotid artery disease is characterised by plaque build-up in the arteries supplying the brain.
The SKYWARD programme includes two planned prospective, multi-centre, single-arm IDE studies, each focusing on transcarotid and transfemoral approaches.
Both will examine the safety and effectiveness of the Shockwave SkyRunner Carotid IVL system in patients at increased risk for complications from carotid endarterectomy.
The system is designed for use before stenting with standard transcarotid or transfemoral stent systems.
Up to 320 subjects are expected to be enrolled, split equally between the two studies, with as many as 50 US sites participating and an additional 25 roll-in patients included in each arm. Long-term follow-up is planned for five years.
The national principal investigators for the studies are Drs William Gray, Nicolas Mouawad, Peter Schneider, and Peter Soukas.
The investigational SkyRunner device has been developed specifically for use in the carotid artery, with features such as rapid exchange capability and tailored sizing to suit both transcarotid and transfemoral procedures.
“Shockwave IVL has become a trusted standard for modifying vascular calcification in coronary and peripheral interventions, and we believe its potential extends well beyond where it’s used today,” said Nick West, chief medical officer of J&J unit Shockwave Medical.
“SKYWARD reflects what happens when innovation is driven in lockstep with physicians’ needs. We listened to what they told us they needed in the carotid space and responded with a first-of-its-kind, purpose-built platform designed for calcific carotid disease.
“This clinical programme is about generating the evidence physicians have asked for so we can expand treatment options and advance outcomes for patients with challenging calcific carotid disease.”
Earlier this month, J&J invested $1bn into strengthening its vision manufacturing capabilities in Florida, part of the company’s broader plans to outlay $55bn into expanding its overall US manufacturing footprint through 2029.
