Innovations in Calcified Carotid Lesion Preparation for Enhanced Stroke Management

Johnson & Johnson has begun enrolling patients in the SKYWARD clinical program, advancing calcified carotid lesion preparation with a purpose-built intravascular lithotripsy platform that fractures hardened plaque to improve stent deployment. This first-of-its-kind carotid IVL system addresses a critical gap in care for patients whose dense arterial calcium makes both surgery and conventional endovascular procedures more hazardous.

Innovative Dual-Access Trial Framework

Two prospective, multicenter, single-arm IDE studies are evaluating the carotid IVL catheter via transcarotid and transfemoral access routes ahead of commercially available stents. Up to 185 participants per pathway, including roll-in cases, will be followed for five years across as many as 50 U.S. centers under the guidance of leading vascular surgeons and interventionalists.

Overcoming Barriers in Calcified Carotid Lesion Preparation

Calcified carotid lesion preparation remains especially challenging when heavy plaque burdens narrow cerebral blood flow and raise complication rates for carotid endarterectomy or stenting. The new rapid-exchange, anatomically optimized IVL catheter directly responds to physician-identified needs, enhancing arterial compliance and enabling more predictable stent apposition where traditional techniques frequently fall short.

Evidence Generation for Future Neurovascular Strategies

Extended five-year outcomes from these high-risk cohorts will supply robust longitudinal data to quantify stroke-risk reduction and economic value. By delivering targeted innovation in calcified carotid lesion preparation, the SKYWARD program lays essential groundwork for expanded endovascular options and informed policy conversations surrounding novel neurovascular technologies.