Hematologic Treatment System Using Ultrasound - Vietnam Registration 2403044ĐKLH/BYT-HTTB

The EKOS 4.0 ultrasound generator is designed to be used with the EKOS thrombolytic treatment kit, which uses high-frequency ultrasound (2 MHz - 3 MHz) at low power to facilitate the delivery of the physician-prescribed liquid, including the liquid used in the procedure and the thrombolytic agent, into the lungs and/or peripheral blood vessels of adults. The EKOS thrombolytic treatment kit is designed to be used with the EKOS control system to use high-frequency ultrasound (2 MHz -3 MHz) at low power to facilitate the delivery of the physician-prescribed liquid, including the surgical liquid and the thrombolytic agent, into the pulmonary arteries and/or peripheral blood vessels of adults. It is intended for use by physicians who are knowledgeable about the percutaneous transluminal angioplasty procedure. The EKOS thrombolytic treatment kit is not designed for use in the central nervous system arteries. The target patient population is adults with symptomatic pulmonary thrombosis and/or peripheral vascular thrombosis, such as the iliac and femoral arteries. Refer to the product information leaflet provided with the physician-prescribed liquid for information on the preparation of the specific liquid, contraindications, side effects, warnings, and precautions. The EKOS thrombolytic treatment kit is indicated for: •the treatment of patients with pulmonary thrombosis with ≥ 50% occlusion of one or both main pulmonary arteries or a lobar artery, and who have evidence of right heart dysfunction based on right heart pressure (pulmonary artery mean pressure ≥ 25 mmHg) or echocardiography. •the delivery of the physician-prescribed liquid, including the thrombolytic agent, into the peripheral arteries and the pulmonary arteries.