May 2, 2012—Ekos Corporation (Bothell, WA) announced the launch of two landmark clinical studies, SEATTLE I and SEATTLE II, which are intended to further establish the safety and efficacy of the Ekos system with EkoSonic ultrasound-accelerated thrombolysis in treating patients with pulmonary embolism (PE). Samuel Z. Goldhaber, MD, is the Principal Investigator for the SEATTLE studies.
SEATTLE I is a multicenter, retrospective analysis of PE patients treated with the Ekos device. Collection of retrospective data for the SEATTLE I study has already begun at nine international sites and should be completed in the fourth quarter of 2012.
SEATTLE II is a multicenter, prospective study of both massive and submassive PE patients treated with the Ekos system. SEATTLE II enrollment will include up to 25 sites and is expected to begin in June 2012 and be completed by mid-2013.
According to Ekos, the EkoSonic endovascular delivery catheters are designed to condition the clot for more rapid absorption of clot-busting drugs. The US Food and Drug Administration (FDA) cleared the Ekos system in 2005. In 2008, the FDA cleared the device to be used in the pulmonary artery. Ekos received the CE Mark to treat massive and submassive PE in January 2010.
The first Ekos PE study, ULTIMA, was launched in 2010. ULTIMA is an international, multicenter, randomized, controlled study comparing submassive PE patients treated with the Ekos system to standard-of-care anticoagulation. This study is more than half enrolled and is expected to be completed in 2013.
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