Device design and applications of the novel JAVELIN peripheral intravascular lithotripsy catheter.

Objective: Moderate or severe vascular calcification is associated with an increased risk of restenosis and need for reinterventions after endovascular treatment of peripheral artery disease. Further, calcification, whether medial, chronic total occlusions with resistant or calcified caps, or calcific nodules, all increase the potential complexity of the intervention. Current calcium modification devices can be limited due to their ability to cross severely stenosed lesions or are associated with an increased risk of vessel damage and distal embolization. The Shockwave Javelin peripheral intravascular lithotripsy (IVL) catheter has no balloon but uses a single IVL emitter located immediately proximal to the tip of the catheter and is designed to modify and cross calcified high-grade stenoses, subtotal occlusions, and occluded vessels. Methods: The prospective, single-arm Mini S Feasibility and FORWARD PAD Investigational Device Exemption studies assessed the safety and effectiveness of the novel Javelin peripheral IVL catheter. One hundred ten subjects with angiographic evidence of moderate to severely calcified peripheral artery disease and Rutherford Category 2 to 5 were enrolled from March 2022 to February 2024. Scenarios well suited for the Javelin IVL catheter became evident in this early experience with the device and are described in detail with case examples. Written informed consent for the collection and publication of data was obtained prior to any study-specific requirements. Results: The primary safety and effectiveness endpoints of the study both met prespecified performance goals: major adverse events (cardiovascular death, clinically driven target lesion revascularization, or unplanned target limb major amputation) at 30 days was 1.1%; technical success (core lab-adjudicated final residual stenosis of ≤50% without flow-limiting dissection) was 99.0%. The study cohort also had significant improvements in residual stenosis and a low rate of serious angiographic complications (1.0%) at final imaging. The Javelin catheter was found to be particularly useful in situations including severely stenosed lesions in smaller diameter infrapopliteal arteries where the fixed diameter due to an absence of a balloon allows for better crossing, calcified nodules, and chronic total occlusions where focal treatment at the tip of the catheter is important. Conclusions: Although the FORWARD PAD Investigational Device Exemption/Feasibility studies showed a favorable safety and efficacy profile, continued real-world assessment will be necessary to understand the long-term performance of the device and how the Javelin peripheral IVL catheter fits into the broader calcium modification algorithm.