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FDA approves EkoSonic to treat pulmonary embolism
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EKOS Corporation today announced that the FDA approved its EkoSonic Endovascular System for the treatment of pulmonary embolism.
According to a press release, the minimally invasive device uses ultrasound for controlled, selective infusion of fluids such as thrombolytics into the vasculature. The device incorporates a small ultrasound device within a drug delivery catheter.
“The EKOS clinical data established that patients stricken with a life-threatening pulmonary embolism can be successfully and safely treated with the EkoSonic system,” Samuel Z. Goldhaber, MD, professor of medicine at Harvard Medical School, stated in the release. “This is the first FDA-cleared treatment option for [pulmonary embolism] since the approval of the drug, tPA, in 1990.”
Samuel Z. Goldhaber
The approval follows results from the ULTIMA trial, published in Circulation in January, which indicated that treatment with EkoSonic was clinically superior to heparin alone for reversing right ventricular dilation within 24 hours, with no increased risk for bleeding complications. In the subsequent prospective, single-arm, multicenter SEATTLE II trial, which evaluated the device in 150 patients, researchers observed a reduced risk for intracranial hemorrhage and pulmonary hypertension, as well as improved right ventricular function, with the use of ultrasound-facilitated, catheter-directed fibrinolysis to treat acute pulmonary embolism.