SEATTLE II Enrollment Completed to Study Ekos' Ultrasound-Accelerated Thrombolyis Device to Treat Pulmonary Embolism

March 20, 2013—Ekos Corporation (Bothell, WA) announced the completion of the SEATTLE II clinical trial, a 150-patient, single-arm, prospective study measuring the rapid reduction in right heart strain in a patient population with both massive and submassive pulmonary embolism (PE) when treated with the EkoSonic ultrasound accelerated infusion catheter. The device generates ultrasound energy while delivering a clot-dissolving drug. According to the company, the ultrasound conditions the clot for more effective drug delivery and aims for faster, more complete clot dissolution.

The SEATTLE II principal investigator, Samuel Z. Goldhaber, MD, is Professor of Medicine at Harvard Medical School and Director of the Venous Thromboembolism Research Group at Brigham and Woman's Hospital in Boston.

“It is almost unheard of to exceed ambitious enrollment goals in any clinical trial. With enrollment of 150 patients from June 2012 through February 2013, SEATTLE II trial recruited patients at a galloping pace that was more than double our expected enrollment rate,” commented Dr. Goldhaber in the company's press release. “This study utilized Ekos in a uniform protocol of thrombolytic (tPA) drug dose and drug infusion time. We instituted uniform inclusion and exclusion criteria, and we amassed an impressive safety record, especially considering that our patient population was gravely ill with either massive or submassive PE.”

Dr. Goldhaber added, “We fully expect to see confirmation of the hemodynamic benefit of rapid aggressive Ekos therapy suggested by previously reported single center studies.”

Although thrombolysis can prevent death and hemodynamic collapse in patients with PE, Dr. Goldhaber advised that the challenge has been to minimize 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.”

On March 9, the company announced that results from ULTIMA, its first randomized trial of the Ekos device for the treatment of PE, demonstrated safety and effectiveness. Data from the ULTIMA trial were presented by principal investigator Nils Kucher, MD, at the 62nd annual scientific session of American College of Cardiology in San Francisco. Regarding this data, Dr. Goldhaber stated, “The results of the ULTIMA trial clearly demonstrate that physicians now have another tool in their armamentarium for the safe and effective treatment of submassive PE.”