EkoSonic System Gains FDA Clearance for Pulmonary Embolism Treatment

May 23, 2014—Ekos Corporation, a BTG International group company, has announced the US Food and Drug Administration clearance of its EkoSonic Endovascular System for the ultrasound-facilitated, controlled, and selective infusion of physician-specified fluids (including thrombolytics) into the vasculature for treating pulmonary embolism (PE). The company states that EkoSonic is now the only minimally invasive therapy on the market that has FDA clearance specifically for the treatment of PE. The device is designed to accelerate the penetration of thrombolytic agents into thrombus.

Results of the 150-patient SEATTLE II clinical trial supporting use of the EkoSonic system in PE were presented at ACC.14 in March, and data from the company’s randomized, controlled trial (ULTIMA) were published in Circulation in January. 

“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, MD, in the company’s press release. Dr. Goldhaber is Professor of Medicine, Harvard Medical School, and Director, Thrombosis Research Group, Brigham and Women’s Hospital, in Boston, and also served as Principal Investigator of the SEATTLE II study. “This is the first FDA-cleared treatment option for PE since the approval of the drug, tPA, in 1990.” 

In a previous release, Dr. Goldhaber commented, “The challenge has been to minimize the major bleeding complication of intracranial hemorrhage, which occurs 10 times more often with IV-administered thrombolysis than with heparin alone. It is no surprise that Ekos, utilizing less than one-fourth of the standard thrombolytic dose, shows a much improved safety record compared with traditional therapy.”

At the International Symposium on Endovascular Therapy (ISET) in January, Barry T. Katzen, MD, commented that the outcome and safety data from ULTIMA were compelling. "This study suggests we should be employing a more aggressive therapeutic approach to these patients with life-threatening pulmonary emboli," said Dr. Katzen, who is Course Director of ISET and Medical Director of the Miami Cardiac and Vascular Institute in Miami.