Javelin: First Non-Balloon IVL Catheter for CTO Lesions Receives FDA Approval

Mar 04, 2025 22:15 CST Updated 22:15

Johnson & Johnson

Healthcare Product Manufacturers, Health Service Providers

Johnson & Johnson announces the launch of its globally first non-balloon IVL catheter in the United States---Javelin。JavelinIt is a novel intravascular lithotripsy (IVL) platform designed to modify calcium and navigate through highly stenotic vessels in patients with peripheral artery disease (PAD).JavelinIt was approved for marketing by the FDA at the end of December last year.

PI Evaluation

"Physicians face significant challenges in treating complex calcified lesions in narrow peripheral vessels, with an increasing demand for more effective crossing and treatment tools. Shockwave's new IVL platform, which offers proven safety and efficacy similar to existing IVL devices, will bring a transformative approach to our peripheral practice, enabling us to enhance case efficiency and optimize outcomes for PAD patients, particularly those with more complex CLTI."

---JD Corl Christ Hospital

Executive Evaluation

"As a pioneer in IVL technology, our goal is to continue delivering innovations that address unmet needs for the physicians we serve. By listening to and leveraging their valuable insights, we have developed a transformative, next-generation IVL platform with unique capabilities to modify calcium and navigate extremely tight vessels. We are proud to be the first to offer interventionalists greater flexibility to meet critical treatment needs and potentially reduce risks associated with CLTI for patients."

---Nick West Chief Medical Officer of Shockwave Medical

Peripheral Artery Disease (PAD): A type of atherosclerosis where fats deposit along the arterial walls, causing narrowing and obstructive lesions, primarily affecting the arteries of the lower limbs and feet.

PAD is a common vascular disease, affecting more than 20 million people in the United States and 202 million people worldwide.

When an artery is blocked by a thrombus, preventing blood from flowing to the lower limbs and feet, PAD will appear. Blockage can lead to poor blood circulation, pain while walking, and changes in skin color.

It is estimated thatPADUp to 40% of patients may have complete vascular occlusion, and these patients often suffer from disabling disabilities or severe limb ischemia. Today's Crossing CTO techniques are very challenging and can easily lead to surgical failure, prolonged operation time, increased radiation exposure for both patients and doctors, and a higher risk of perioperative complications and repeat interventions.

As the pioneer of shock wave technology for treating vascular calcification, Johnson & Johnson also hopes toShock WaveTechnology for TreatmentComplete OcclusionBlood vessels, but the previously developed balloon-based IVL catheter clearly could not fulfill this wish. To this end, Johnson & Johnson developed a balloon-free IVL catheter based on the previous IVL catheter---Javelin。JavelinAchieve the placement of the shock wave generator at the distal end of the catheter, thereby continuously breaking up proximal vascular calcified lesions with shock waves, and gradually reopening the vessel.Complete OcclusionBlood vessels.

Javelin

JavelinIt is a new type of shockwave catheter, which is different from the traditional balloon-type shockwave catheter in that it has no balloon andThe shock wave generator is set at the farthest end of the catheter, thereby achievingTransmit shock waves to the front of the catheter, using shock waves to open occluded vessels.

JavelinThe catheter includes a flushing lumen, a guidewire lumen, a pressurization lumen, and a shock wave generator.

The pressurized chamber can be filled with saline to achieve a predetermined therapeutic pressure.
Flushing the catheter lumen allows for flushing the treatment area with saline.
The guidewire lumen is used for passing through aA 0.014" (0.36 mm) guidewire to facilitate passage through occluded vascular segments under guidewire guidance.

According to Johnson & Johnson's introduction, oneJavelinThe catheter can deliver 12 rounds of shock waves, with each round consisting of 10 shocks, for a total of 120 shocks.

JavelinIt is very easy to use, and a simple four-step process can open the occluded blood vessel.

Currently,JavelinOnlyApplicable for shock wave lithotripsy and crossing peripheral arterial calcified lesions, including iliac arteries, femoral arteries, iliofemoral arteries, popliteal arteries, and infrapopliteal arteries. FutureJavelinThe technology can also be applied to the coronary artery.

JavelinDemonstration

Shockwave Medical

ShockWave MedicalAs part of Johnson & Johnson's medical device division, its aim is to improveTreatment Methods for Calcified Cardiovascular Diseases.ShockWave MedicalThe goal is to establish a new standard for medical device treatment of cardiovascular calcification diseases through its differentiated and proprietary localized delivery of ultrasound for the treatment of calcified plaques, which they callIntravascular Lithotripsy（“IVL”）。