Shockwave Javelin: Johnson & Johnson's Novel Non-Balloon IVL Catheter for Peripheral Arterial Disease

Currently, Johnson & Johnson has two types of IVL products --- one is balloon-shaped.Shockwave IVL and a non-balloon-shapedShockwave Javelin. These two productsProducts can be used for the treatment of peripheral arterial disease, includingModification and traversal of calcified lesions in the peripheral vascular system, including the iliac artery, femoral artery, iliofemoral artery, popliteal artery, and infrapopliteal artery, assisted by intravascular lithotripsy (IVL).Shockwave Javelin isThe First Forward IVL Platform with ShockwaveIt is characterized by a single emitter located at the distal end of the catheter tip, capable of fragmenting calcifications ahead of the catheter to assist in modifying and crossing calcified occlusive lesions.

Design Details of Shockwave Javelin

• Comparison of Usage Methods

Use of Shockwave IVLWhen the balloon must pass through the calcified lesion for effective treatment.

Use of Shockwave JavelinWhen the Shockwave Javelin's emitter is located at the distal tip of the catheter, this allows the acoustic pressure wave to be more effective than the Shockwave IVL.Release closer to the calcified occlusion lesion.

• Sound Wave Output Mode
  

The Shockwave Javelin emitter has a spherical acoustic output similar to traditional balloon-type IVL devices, meaning its calcium modification effect is comparable. Since the emitter is positioned close to the distal end of the catheter, its spherical acoustic output range extends forward beyond the distal end of the catheter, enabling it to fragment calcifications ahead of the catheter. This ability to fragment calcifications in front of the catheter allows it to modify and traverse difficult-to-cross lesions.

• Catheter Design Structure
  

Shockwave Javelin has only one IVL emitter, located at the distal end of the catheter.Non-expandable IVL WindowWithin.IVL WindowContaining saline, it enables energy transfer from the emitter to the calcified tissue. Its enhanced catheter shaft provides pushability, flexibility, and kink resistance to optimize device deliverability in complex anatomical structures. The distal segment of the catheter is more flexible and features a hydrophilic coating, improving trackability and deliverability.

Shockwave Javelin Parameter Information

• Shockwave Javelin IVL Window
  

IVL WindowMade of non-compliant materials, it does not expand when pressurized, ensuring a stable passage profile.IVL WindowThe function is the same as the balloon on traditional balloon-type devices, mainly serving two purposes:

Achieve Lithotripsy:IVL WindowFilled with saline, in contact with the transmitter for lithotripsy.

Promote Energy Transfer:IVL WindowAttached to the occlusive lesion, it helps efficiently transfer IVL energy from the emitter to the calcified tissue. During the treatment process, after every 10 pulses (one cycle) are emitted, flushing is required.IVL WindowAnd re-inject saline to remove bubbles and ensure effective ultrasonic output.

• Usage of Shockwave Javelin

Shockwave Javelin Clinical Data

Johnson & Johnson has announced two clinical studies on Shockwave Javelin: the Feasibility Study and the FORWARD PAD IDE Study.

Between 2022 and 2024, two studies enrolled 90 patients with 103 lesions across 19 centers. The average age was 74.5±9.3 years, 56.7% had diabetes, and 18.9% had renal insufficiency. Preoperative lesion characteristics included a mean diameter stenosis of 82.9%±16.7%, a mean lesion length of 76.9±59.4 millimeters; 38% of the lesions were chronic total occlusions (CTO), and 82.5% were severely calcified.

Specific Research Data

• Despite severe calcification and significant stenosis of the lesions, the Shockwave Javelin successfully crossed most of them (device crossing success rate: 93% [107/115]).

• The primary effectiveness endpoint --- defined as final residual stenosis ≤50% and no flow-limiting dissection --- achieved the pre-specified performance goal (99.0%; P < .0001).

• The primary safety endpoint --- defined as the composite endpoint of cardiovascular death, clinically driven target lesion revascularization (TLR), or unplanned major amputation of the target limb (above the ankle) within 30 days --- also met the pre-specified performance goal (1.1%; P = .0012).

• The safety profile of Shockwave Javelin has been shown to be consistent with traditional Shockwave IVL, with a low incidence of angiographic complications.

• The effectiveness of Shockwave Javelin has been proven to be consistent with traditional Shockwave IVL, with a similar reduction in diameter stenosis.

Summary

Through the Shockwave Javelin feasibility study, FORWARD PAD IDE study, and early commercial application experience, Shockwave Javelin has demonstrated its ability to safely and effectively modify calcifications and cross challenging lesions, including chronic and sub-total occlusions as well as severely narrowed vessels.