J&J Starts Pivotal SkyRunner Carotid IVL Trials

Johnson & Johnson has initiated pivotal development of SkyRunner, a Shockwave Medical device designed to treat calcified carotid arteries using intravascular lithotripsy technology. Announced on 29 June 2026, the first patient has already been treated in Michigan under an investigational device exemption programme, marking the first pivotal-stage IVL programme in carotid disease and extending J&J’s push to expand Shockwave’s technology beyond coronary and peripheral arteries.

Carotid artery disease develops when plaque accumulates in vessels supplying blood to the brain, narrowing or blocking arteries and raising stroke risk. Current treatment options are limited, particularly for patients considered too high risk for carotid endarterectomy. SkyRunner is designed to expand those options by removing calcium and preparing arteries for stenting, with vessel-specific sizing and shaft lengths for both transcarotid and transfemoral access. Each of the two pivotal trials will enrol up to 160 high-risk patients with a composite primary endpoint of death, stroke and myocardial infarction, with primary completion in late 2027 and follow-up through 2032.

J&J acquired Shockwave Medical for $13.1 billion in 2024, having identified expansion into carotid arteries and structural heart disease as a strategic priority for the platform. Off-label use of existing Shockwave products in carotid stenting has already emerged in clinical practice, giving SkyRunner a receptive interventional community heading into pivotal trials. Competitive pressure is intensifying, with Boston Scientific having acquired Bolt Medical for $664 million last year and posting positive coronary IVL data in May, and Stryker entering the market through its acquisition of Amplitude Vascular Systems earlier this year.

The commercial signal is J&J executing on the Shockwave acquisition thesis at exactly the moment IVL becomes a genuinely contested category. Extending into carotid arteries opens a substantial new addressable market with clear unmet need, particularly among high-risk surgical patients. The Boston Scientific and Stryker moves confirm the strategic value of the IVL category and set up an intensifying competitive dynamic through 2027.

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