Johnson & Johnson Launches Pivotal FORWARD CAD IDE Study of Javelin, First Non-Balloon IVL Catheter for Coronary CTO Lesions, Enrolls First Patient

Johnson & Johnson announced the launch of itsThe First Non-Balloon IVL Catheter--JavelinPivotal FORWARD CAD Study (IDE). This study aims to evaluateJavelinSafety and Efficacy of Treating Calcified and Difficult-to-Pass Stenotic De Novo Coronary Lesions Before Stent Placement, with First Patient Clinical Enrollment Completed in the United States.

PI Evaluation

"The current treatment for severe coronary artery calcification and stenosis still relies on plaque debulking when balloon technology fails to pass through, indicating an opportunity for improvement in treatment methods."

---Evan Shlofmitz  St. Francis Hospital 

"We are pleased to enroll the first patient in the FORWARD CAD clinical trial, which will evaluate whether Shockwave's innovative forward IVL platform can help reduce the known risks associated with plaque excision for these patients."

---Ziad Ali St. Francis Hospital 

Executive Evaluation

"We are always committed to exploring the full potential of IVL technology in optimizing cardiovascular care. We believe Javelin is expected to revolutionize the way interventional cardiologists treat severe calcified stenotic lesions. We look forward to laying the foundation for a new era of improved treatment outcomes for complex coronary heart disease patients through enhanced IVL capabilities."

---Nick West  Chief Medical Officer of Shockwave Medical

Coronary Artery Disease (CAD) is the most common type of heart disease, affecting approximately 1 in every 20 adults over the age of 20 in the United States. In this condition, cholesterol-rich deposits gradually narrow the coronary arteries, reducing blood flow to the heart muscle and leading to chest pain (angina) and heart attacks. Over time, these narrowed vessels may harden and become blocked due to calcium deposits, making treatment with conventional techniques more challenging.

Traditional balloon-shaped IVL forSevere calcified stenotic lesions are basically helpless because this type of IVL cannot pass through the stenotic segment, thus failing to deliver the IVL effect. To address this issue, Johnson & Johnson has developed a non-balloon-shaped IVL catheter---Javelin, it adopts a single distal transmitter design that generates ultrasonic shock waves, with its spherical energy field extending beyond the catheter tip. Compared to traditional balloon-shaped IVL, this innovative design brings lithotripsy energy closer to highly stenotic calcified lesions.Thereby continuously crushing proximal vascular calcified lesions through shock waves, gradually reopening the pathway.Complete OcclusionBlood vessels.

Currently used for peripheralSevere Calcified Stenotic LesionTherapeuticJavelinHas already received FDA approval for market release, while its application in the coronary field has entered clinical research. Johnson & Johnson isSevere Calcified Stenotic LesionIn terms of treatment, it continues to lead, widening the gap with competitors such as Boston Scientific and Abbott.

JavelinIt is a new type of shockwave catheter, which is different from traditional balloon-type shockwave catheters 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, and use shock waves to open occluded blood vessels.

• The pressurized chamber can be filled with saline to achieve the desired treatment pressure.

• Flushing the catheter lumen allows for irrigation of the treatment area with saline solution.

• The guidewire lumen is used for passing through aA 0.014" (0.36 mm) guidewire to facilitate passage through occluded vessels under guidewire guidance.