Johnson & Johnson Launches Shockwave E8, the World’s Longest Intravascular Lithotripsy Balloon, Following FDA Approval

Peripheral arterial disease is a type of peripheral vascular disease (PVD).PAD is a chronic limb ischemic disease. Clinically, vascular diseases other than cardiovascular and cerebrovascular diseases are collectively referred to as peripheral vascular diseases. Peripheral vessels mainly include peripheral arteries and veins.

The main cause of peripheral vascular disease isAtherosclerosis, gradually forming plaques that cause thrombosis, followed by calcification leading to vascular occlusion.In a few cases, arteriosclerosis can lead to arterial wall damage and weakening, forming an aneurysm. The main clinical manifestations include limb swelling, limb pain, and intermittent claudication.

The prevalence of peripheral artery disease in China is approximately 3.67%.The main cause of peripheral artery disease is atherosclerosis, and the risk of developing peripheral artery disease gradually increases with age. The number of patients with peripheral artery disease in China grew from 47.113 million in 2017 to 51.872 million in 2021, with a compound annual growth rate of 2.43%. This is due to China's aging population and rapid economic development.The number of patients with peripheral artery disease will continue to increase in the future.It is estimated that by 2030, the number of patients will increase to 62.3044 million., with a compound annual growth rate of 2.06% from 2021 to 2030.

• March 2023,Shockwave Medical TheShockwave L6 Peripheral Vascular Lithotripsy CatheterObtained FDA Approval, to treat difficult-to-treat calcified lesions in large peripheral vessels (including the iliac artery and common femoral artery).
• January 2024,FastWave Medical(Grand Pharmaceutical Acquisition) Developed Peripheral VascularFastWave IVL SystemSuccessful Completion of First Human Study Enrollment, will evaluate the safety and performance of the IVL system in patients with moderate to severe calcification in the superficial femoral or popliteal arteries affected by peripheral artery disease. The system features a highly deliverable, low-profile, anti-burst balloon capable of generating lasting and predictable circumferential ultrasonic pressure.
• May 2024,Amplitude Vascular Systems(AVS)Pulse IVL FDA Approved for IDE Study (POWER-PAD-II)，Evaluate the Safety and Efficacy of Pulse IVL in Treating Patients with Severe Calcified Peripheral Artery Disease. Instead of using pressure waves generated by cavitation to break up calcified plaques, this system pulverizes vascular calcium through high-frequency, pulsating pressure waves generated inside the balloon, aiming to alleviate vascular blockages caused by severe calcification and restore blood flow.

• November 2021,Spectrum MedicalTheSonico-PX Peripheral Vascular Intravascular Shockwave Balloon CatheterLaunched the first registration clinical trial in China for a domestically produced peripheral intravascular shockwave lithotripsy system, currently in the registration phase.The innovative design of the hydroelectric shockwave balloon catheter system enhances the 360° axial distribution of shockwaves in blood vessels, reduces the concentration of sound waves, and uniformly fractures circumferential calcified plaques, effectively breaking down calcified plaques.
• February 2022,Lepu MedicalFor peripheral arteriesAngiocrack™ Pulsed Acoustic Wave Balloon SystemCompletion of the First Severe Calcification Lesion Surgery in the Popliteal ArteryClinical enrollment has been completed, and efforts to advance product registration are currently underway.
• June 2023,Nanjing Xinke MedicalThePeripheral Shock Wave Balloon SystemSuccessful Enrollment of the First Patient in the Pre-Market Clinical Study for the Treatment of Lower Extremity Arterial CalcificationCompared with traditional shock wave products based on hydraulic technology, this product safely and efficiently fragments deep calcification without damaging the vascular endothelium through non-focused, pulsed shock waves induced by micro-pores."Micro-pore Induction" - A World FirstShock waves significantly reduce the voltage threshold required for liquid cavitation, increase the number of product uses, and lower the risks during product usage.
  In this clinical application, the patient's lower limb arterial calcification lesion was treated with one cycle (30 pulses) of the shock wave balloon.Angiography showed a reduction in stenosis of the target lesion in peripheral vessels, no complications occurred, and safety was good.And during the surgery, no drug-coated balloon was used and no stent was implanted, achieving the goal of interventional treatment without implantation.
• August 2023,Huihe Medical (Zhonghui Medical)Disposable Peripheral Vascular Intravascular Shockwave Catheter (C-Wave® System) received NMPA approval for marketing,Pre-dilation and balloon dilation were performed on calcified lesions (vascular stenosis ≥50%) in the iliac artery, femoral artery, iliofemoral artery, popliteal artery, renal artery, and infrapopliteal artery of adult patients. C-Wave® becameThe First Domestically Produced Shock Wave System in China to Hit the Market, and it is also the second intravascular lithotripsy product to be launched globally.
  C-Wave® isWorld's First 360° Full-sector Calcification Shock Wave System, with "Spiral Electrode ArrangementStructure (Shockwave adopts a circumferential electrode arrangement), effectively dilates occluded vessels and gains vascular lumen by utilizing shockwaves generated from electrodes inside the balloon that are in good contact with calcified lesions, significantly reducing stent implantation.
• June 2024,Saihe Medical'sLiqMagic® Peripheral Shock Wave CatheterRelease of Clinical Study Results for Peripheral Artery Vascular Calcification Lesions – CRACK-PAD Trial, confirming the effectiveness of intravascular shockwave therapy for calcified lesions and the significant immediate lumen gain after applying shockwave treatment.The technical success rate of the primary endpoint reached 98.46%.; The degree of stenosis in the target lesion was significantly reduced after the use of intravascular lithotripsy, decreasing from 93.72% pre-procedure to 11.01% post-lithotripsy treatment, and further reducing to just 4.89% after combination with other treatment methods.