Shockwave Medical, now a unit of Johnson & Johnson MedTech, has announced positive clinical outcomes for its Javelin peripheral intravascular lithotripsy (IVL) catheter system. The Javelin catheter is designed to modify calcium and facilitate crossing in extremely narrowed vessels in patients suffering from peripheral artery disease (PAD). The recent data supports FDA clearance and suggests a promising alternative for treating challenging lesions.
The Javelin IVL catheter features a single 120-pulse lithotripsy emitter at its distal tip. It is specifically designed for use in sub-total occlusions or severely narrowed vessels where standard devices struggle to cross. The device emits sonic pressure waves spherically from the forward-shifted emitter, modifying obstructive calcification and enabling device crossing.
Javelin IVL Achieves Primary Endpoints
The 30-day results from studies of the Javelin catheter demonstrated that it met both pre-specified performance goals and exhibited a safety and effectiveness profile comparable to Shockwave's balloon-based IVL catheters. The device yielded a major adverse event rate of 1.1% at 30 days and a technical acute procedural success rate of 99%. Angiographic complications were minimal, with only one reported case of dissection and no perforations, abrupt vessel closure, distal embolization, or no-reflow.
The data comes from the MINI S feasibility study and the FORWARD PAD investigational device exemption (IDE) study, which together enrolled 90 patients with 103 heavily calcified, stenotic peripheral arterial lesions.
According to Dr. Nick West, chief medical officer at Shockwave Medical, the company is "extremely optimistic about the role that Shockwave Javelin could play in offering an effective alternative crossing and treatment tool with a strong safety profile," especially considering the risks associated with treating difficult-to-cross lesions using other modalities. A limited market release of the device is anticipated in the coming months, with ongoing trial follow-up to further assess its performance.
DISRUPT BTK II Study Highlights IVL Efficacy
In addition to the Javelin catheter results, Shockwave also presented 30-day primary endpoint data from the DISRUPT BTK II study. This post-market study evaluated the safety, effectiveness, and optimal clinical use of Shockwave's peripheral IVL system for treating calcified peripheral lesions below the knee (BTK), including patients with critical limb threatening ischemia (CLTI).
The DISRUPT BTK II study, led by Dr. Venita Chandra and Dr. Ehrin Armstrong, was a prospective, multi-center, core-lab adjudicated, single-arm study involving 250 patients with 305 lesions across 38 sites globally. The patient population was complex, with 46% presenting with baseline wounds, 80% with CLTI, 70% with diabetes mellitus, 30% with chronic total occlusions (CTOs), and 85% with moderate-to-severe calcium.
The study met its primary effectiveness endpoint, demonstrating a procedural success rate of 97.9% residual stenosis for all treated target lesions without serious angiographic complications. It also met its primary safety endpoint, with a major adverse limb event (MALE) or post-operative death (POD) rate of 0.8% within 30 days of the procedure. Furthermore, 49% of treated limbs showed improvement from their RC baseline within 30 days, and patients experienced a statistically significant improvement in VascuQol scores.
Dr. Armstrong noted that patients will be followed for two years to assess the long-term durability of the 30-day data in this challenging patient population. He expressed anticipation for further analyses to optimize the use of IVL in improving outcomes for these difficult-to-treat patients.
