Johnson & Johnson’s (J&J) Shockwave Medical unit has reported that its Javelin peripheral intravascular lithotripsy (IVL) catheter system successfully met the primary endpoints in a clinical trial, demonstrating both safety and efficacy for treating patients with peripheral artery disease (PAD).
Designed to address heavy calcified, narrow blood vessels, the Javelin catheter uses a novel, non-balloon-based lithotripsy platform to modify calcium, enabling access to vessels that are highly stenotic or otherwise challenging to cross.
In contrast to traditional balloon-based systems, this approach aims to offer a more targeted and less invasive method for managing complex vascular disease.
Key trial data showed that the Javelin catheter met prespecified safety and effectiveness goals at 30 days, with a major adverse event rate of just 1.1% and a technical acute procedural success rate of 99%. In final angiography, complications were minimal, with only one reported case of dissection and no instances of perforation, abrupt closure, distal embolisation, or no-reflow.
The trial data included outcomes from the MINI S feasibility study and FORWARD PAD investigational device exemption (IDE) study, which enrolled 90 patients with 103 heavily calcified, stenotic peripheral arterial lesions. According to the company, these results supported US Food and Drug Administration (FDA) clearance for the catheter last month.
J&J inherited Shockwave, as well as the Javelin catheter, in June 2024 as part of a $13.1bn deal to strengthen its cardiovascular portfolio. This acquisition follows two other recent high value moves by J&J - the $16.6bn purchase of heart recovery company Abiomed in November 2022 and a $400m upfront payment to acquire atrial fibrillation device maker Laminar in December 2023.
Shockwave Medical’s chief medical officer Nick West said: “We look forward to learning more about the performance of the Shockwave Javelin IVL catheter as we add to the ongoing trial follow-up data with a limited market release of the device in the coming months.”
PAD is a common vascular condition that affects both quality of life and life expectancy with an associated increased risk of cardiovascular events. PAD patients have narrowed arteries, usually due to atherosclerosis, where fatty deposits build up on the artery walls, restricting blood flow. According to GlobalData’s Medical Intelligence Center, the cardiovascular devices market will generate $116.8bn in 2033.
