ULTIMA Will Study Treatment of Pulmonary Embolism Using the Ekos EkoSonic Endovascular Device

January 18, 2010—Ekos Corporation (Bothell, WA) announced that the company is in the final planning and approval stages for the ULTIMA (Ultrasound Accelerated Thrombolysis of Pulmonary Embolism) randomized clinical study.

According to ULTIMA's principal investigator, Nils Kucher, MD, the study's objective is to show that treatment with low-dose, ultrasound-accelerated thrombolysis with the company's EkoSonic endovascular device will rapidly improve right heart failure patients without introducing the risk of bleeding complications, typically associated with systemic thrombolytic therapy.

"This study is, to our knowledge, the first randomized, controlled trial designed to show the clinical benefit of an endovascular device to treat acute submassive pulmonary embolism in comparison to anticoagulation therapy alone," commented Dr. Kucher.

In the ULTIMA study, 50 patients with pulmonary embolism and enlarged right hearts will be randomized to receive either standard-of-care anticoagulation or Actilyse (Boehringer Ingleheim GmbH, Ingelheim am Rhein, Germany) delivered via the EkoSonic device. Ekos stated that the amount of drug necessary to dissolve a blood clot is significantly reduced when using the EkoSonic system because ultrasound increases the permeability of the clot while gently driving the drug into its interior. The company anticipates that delivery of Actilyse directly into the pulmonary embolism in the presence of the ultrasound generated by the EkoSonic device will result in prompt, complete dissolution of the obstructing embolism with restoration of right heart function and a reduction in the number of patients with long-term side effects from pulmonary emboli. ULTIMA enrollment is expected to commence in the first quarter of 2010 and be completed by the first quarter of 2011, the company advised.