09.11.14
Ekos Corp. received U.S. Food and Drug Administration (FDA) clearance for its EkoSonic endovascular system for the ultrasound-facilitated infusion of physician-specified fluids, including thrombolytics, into blood vessels for the treatment of pulmonary embolism (PE).
According to the company, the ultrasonic devices are designed to gently accelerate the penetration of thrombolytic agents (clot-busting drugs) into thrombus (commonly called blood clots), providing high levels of lysis (the breaking down of a cell). Ekos officials claim their technology 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 United States, causing or contributing to 200,000 deaths each year, according to the Society of Interventional Radiology. PE also causes or contributes to 15 percent of all hospital deaths.
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., said: “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.”
“Interventional radiologists, cardiologists, cardiothoracic and vascular surgeons at leading institutions around the world use our system to provide faster, safer and more complete dissolution of thrombus,” said Matt Stupfel, general manager of Ekos. “We are proud to have completed the world’s only randomized controlled trial and the largest prospective single-arm trial on the safety and effectiveness of Ekos therapy in the treatment of PE. The positive outcomes of those trials, combined with our expanded indication will allow a better standard of care for thousands of patients who suffer from PE.”
Bothell, Wash.-based Ekos is a division of BTG International Ltd. in London, the United Kingdom, that develops and markets products targeting acute care, cancer and vascular diseases.
According to the company, the ultrasonic devices are designed to gently accelerate the penetration of thrombolytic agents (clot-busting drugs) into thrombus (commonly called blood clots), providing high levels of lysis (the breaking down of a cell). Ekos officials claim their technology 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 United States, causing or contributing to 200,000 deaths each year, according to the Society of Interventional Radiology. PE also causes or contributes to 15 percent of all hospital deaths.
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., said: “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.”
“Interventional radiologists, cardiologists, cardiothoracic and vascular surgeons at leading institutions around the world use our system to provide faster, safer and more complete dissolution of thrombus,” said Matt Stupfel, general manager of Ekos. “We are proud to have completed the world’s only randomized controlled trial and the largest prospective single-arm trial on the safety and effectiveness of Ekos therapy in the treatment of PE. The positive outcomes of those trials, combined with our expanded indication will allow a better standard of care for thousands of patients who suffer from PE.”
Bothell, Wash.-based Ekos is a division of BTG International Ltd. in London, the United Kingdom, that develops and markets products targeting acute care, cancer and vascular diseases.