The FDA has cleared the EkoSonic Endovascular System for the ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism (PE), according to manufacturer EKOS Corp.
The EKOS ultrasonic devices are designed to gently accelerate the penetration of thrombolytic agents into thrombus, providing high levels of lysis. EKOS is the only minimally invasive endovascular therapy on the market that has been FDA cleared for the treatment of PE.
PE occurs in approximately 600,000 patients in the US, causing or contributing to 200,000 deaths each year. PE also causes or contributes to 15% of all hospital deaths.
“The EKOS clinical data established that patients stricken with a life-threatening pulmonary embolism can be successfully and safely treated with the EkoSonic system. This is the first FDA cleared treatment option for PE since the approval of the drug, tPA, in 1990,” said Samuel Z. Goldhaber, MD, professor of Medicine, Harvard Medical School.
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