Shockwave Medical Presents First Clinical Outcomes of New IVL Platform at VIVA 2024

A pioneering device known as the Shockwave Javelin Peripheral IVL Catheter has shown significant promise in treating peripheral artery disease (PAD). Shockwave Medical, Inc., which operates under the Johnson & Johnson MedTech umbrella, has introduced this advanced non-balloon-based lithotripsy platform designed to address calcified lesions and facilitate the crossing of extremely narrow blood vessels. The innovative catheter was presented at the Vascular InterVentional Advances (VIVA) meeting, highlighting its potential to revolutionize PAD treatments.

The Shockwave Javelin Peripheral IVL Catheter has received the U.S. Food and Drug Administration (FDA) clearance, marking a significant milestone for the technology. The catheter is distinguished from traditional balloon-based IVL catheters by its single 120-pulse lithotripsy emitter located at the distal tip. This emitter produces sonic pressure waves that modify calcifications, thereby enabling the device to cross and treat severely narrowed or partially occluded blood vessels. The device's capability to handle challenging lesions and its favorable safety profile were underscored by the clinical outcomes.

Dr. JD Corl, the Medical Director of the PAD/CLI Program at The Lindner Center for Research and Education at The Christ Hospital, praised the catheter's performance. He noted that the initial data indicate a strong safety profile and effective outcomes, suggesting that the Shockwave Javelin Peripheral IVL Catheter could become an essential tool in treating PAD, particularly in cases involving difficult-to-cross lesions.

Peripheral artery disease affects over eight million Americans older than 40, leading to compromised quality of life and higher risks of heart attacks and strokes. Chronic limb-threatening ischemia (CLTI), the most severe form of PAD, afflicts almost two million people in the U.S. and is linked to high rates of major amputations and mortality. The advent of the Shockwave Javelin Peripheral IVL Catheter offers a promising new avenue for improving outcomes for these patients.

The recent studies, MINI S and FORWARD PAD, were designed to evaluate the feasibility and safety of the catheter. These prospective, multi-center, single-arm, angiographic core-lab adjudicated studies enrolled 90 patients with 103 heavily calcified peripheral arterial lesions. The studies demonstrated an average lesion length of 77mm, with nearly half of the target lesions situated below the knee and over a third being chronic total occlusions. The catheter met its prespecified safety and effectiveness endpoints, showing a major adverse event rate of just 1.1% at 30 days and a technical procedural success rate of 99%. Notably, there was only one case of dissection reported, with no instances of perforations, abrupt vessel closures, distal embolization, or no-reflow.

Dr. Nick West, Chief Medical Officer at Shockwave Medical, expressed optimism about the catheter's role in treating PAD, especially for patients with lesions that are difficult to cross using other modalities. He highlighted the strong safety profile and effectiveness of the Shockwave Javelin Peripheral IVL Catheter, indicating that further trial follow-up data would be collected as the device undergoes a limited market release in the coming months.

Shockwave Medical continues to lead in the development of innovative products that transform cardiovascular treatment. Their Intravascular Lithotripsy (IVL) technology uses sonic pressure waves to disrupt calcified plaque, significantly improving patient outcomes in atherosclerotic cardiovascular disease treatments. The Shockwave Javelin Peripheral IVL Catheter represents a major advancement in the management of PAD, offering new hope to millions of patients suffering from this debilitating condition.