On 2 May 2012, EKOS Corporation announced the launch of two clinical studies named SEATTLE I and II, intended to further establish the safety and efficacy of its ultrasound-accelerated thrombolysis in treating patients with life-threatening pulmonary embolism.
The SEATTLE I and II studies are, respectively, a multicentre, retrospective analysis of pulmonary embolism patients treated with EKOS, and a multicentre, prospective study of both massive and submassive pulmonary embolism patients treated with EKOS. The principal investigator for the SEATTLE series is Samuel Z Goldhaber, professor of Medicine at Harvard Medical School, and director of the Brigham and Women’s Hospital Venous Thromboembolism Research Group. The first patients to be enrolled in SEATTLE II are expected in June 2012 with complete enrolment from up to 25 study sites expected by mid 2013.
Collection of retrospective data for the SEATTLE I study has already begun at nine international sites and should be completed in Q4 2012.
EKOS launched its first pulmonary embolism study, ULTIMA, in 2010 with lead principal investigator Nils Kucher of Bern University Hospital, Switzerland. ULTIMA is an international, multicenter, randomised, controlled study comparing submassive pulmonary embolism patients treated with EKOS to standard-of-care anticoagulation. This study is more than half enrolled and is expected to be completed in 2013.