EkoSonic Endovascular System Receives FDA Clearance

EKOS Corporation, a BTG International group company, has won approval from the U.S. Food and Drug Administration (FDA) for its 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).

The EKOS ultrasonic devices are designed to gently accelerate the penetration of thrombolytic agents into thrombus, providing high levels of lysis. EKOS claims its minimally invasive endovascular therapy is the only one on the market that has been FDA cleared for the treatment of PE, a condition that affects roughly 600,000 U.S. patients and contributes to 200,000 deaths annually. PE also causes or contributes to 15 percent of all hospital deaths, according to industry statistics.

“The EKOS clinical data established that patients stricken with a life-threatening pulmonary embolism can be successfully and safely treated with the EkoSonic system,” said Samuel Z. Goldhaber, M.D., professor of Medicine at Harvard Medical School and director of the Thrombosis Research Group at Brigham and Woman’s Hospital in Boston, Mass. “This is the first FDA cleared treatment option for PE since the approval of the drug, tPA, in 1990.”

In January, the outcomes of a clinical trial called Ultima were published in American Heart Association’s Journal, Circulation. The trial demonstrated that for PE patients at intermediate risk of adverse events, EKOS treatment was clinically superior to anticoagulation with heparin alone in reversing right ventricular dilation at 24 hours, without an increase in bleeding complications.

The company also released the results of Seattle II, a prospective single-arm multi-center trial of 150 patients, at this year’s American College of Cardiology conference. The Seattle II trial demonstrated that ultrasound-facilitated catheter-directed low-dose fibrinolysis for acute PE minimizes the risk of intracranial hemorrhage, improves RV function, and decreases pulmonary hypertension.

BTG is an international specialist healthcare company that develops and commercializes products targeting acute care, cancer and vascular diseases.

EKOS Corporation develops ultrasound infusion technologies, introducing its first system for the treatment of vascular thrombosis in 2005.