Ekos' Devices to Be Studied

January 18, 2010—Ekos Corporation (Bothell, WA) acknowledged the beginning of the physician-sponsored DUET study. DUET is a Dutch multicenter randomized trial designed to compare ultrasound-accelerated catheterdirected thrombolysis to standard catheter-directed thrombolysis in patients with recently thrombosed infrainguinal native arteries or bypass grafts. The study's hypothesis is that ultrasound-accelerated thrombolysis with the Ekos device will significantly reduce therapy time (by at least 12 hours) compared to standard thrombolysis alone without increasing the complication rate.

The DUET study's principal investigator is Jean-Paul de Vries, MD, of St. Antonius Hospital Nieuwegein in The Netherlands.

According to Dr. de Vries, a total of 60 adult patients with recently (between 1 and 7 weeks) thrombosed infrainguinal native arteries or bypass grafts with acute limb ischemia Rutherford class I and IIa will be randomly allocated to either group A (standard thrombolysis) or group B (Ekos ultrasound-accelerated thrombolysis). The anticipated duration of recruitment will be 1 year. The primary endpoint is the duration of catheter-directed thrombolysis needed for uninterrupted flow in the thrombosed infrainguinal native artery or bypass graft with outflow via at least one crural artery.

“Current therapy can take a significant amount of time during which the patient is restricted to a bed in a hospital monitoring unit, and bleeding complications increase with duration of thrombolysis,” commented Dr. de Vries. “This new ultrasound-accelerated technology promises to significantly reduce the treatment time. Such a reduction, if proven, could reduce treatment costs, patient discomfort, and the risk of bleeding, which is sometimes associated with these types of drugs.”

Ekos also announced that the company is in the final planning and approval stages for the ULTIMA (Ultrasound Accelerated Thrombolysis of Pulmonary Embolism) randomized clinical study.

ULTIMA's principal investigator, Nils Kucher, MD, stated that 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 Ingelheim 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.