BOTHELL, Wash.--()--EKOS Corporation announced today that they are in the final planning and approval stages of a randomized clinical study for the treatment of pulmonary embolism, known as the ULTrasound Accelerated ThrombolysIs of PulMonAry Embolism (ULTIMA) Study.
President/CEO Robert W. Hubert said, “We are pleased to announce that Dr. Nils Kucher, an internationally known expert on pulmonary embolism, University Hospital (Bern, Switzerland), will be the Principle Investigator for the study. Dr. Kucher will be joined by colleagues from the University Hospitals in Dresden, Munich and Greifswald, Germany, and several other sites. Dr. Kucher noted, “This study is, to our knowledge, the first randomized controlled trial designed to show the clinical benefit of an endovascular device to treat acute sub massive pulmonary embolism in comparison to anticoagulation therapy alone. We intend to show that treatment with low-dose, ultrasound accelerated thrombolysis [EKOS] will rapidly improve right heart failure in these patients, without introducing the risks typically associated with systemic thrombolytic therapy.”
Pulmonary embolism occurs at a rate of approximately 24 per 100,000 people and accounts for up 150,000 to 500,000 deaths per year in the United States and Europe and effects more than 1,600,000 patients annually. Serious pulmonary emboli interfere with the heart's ability to pump blood into the lungs for oxygenation, causing enlargement of the right side of the heart, and potentially causing death. Current treatments typically involve aggressive anti-coagulation, or in the most serious cases, intravenous delivery of clot dissolving, thrombolytic agents. Anti-coagulants do not dissolve the embolism but can reduce the mortality rate. Thrombolytics actively dissolve the embolus, but are associated with an increased risk of bleeding. Neither therapy completely dissolves the embolus in all patients, leaving some patients with a chronic clot.
Hubert added, “In the ULTIMA study, 50 patients with pulmonary embolism and enlarged right hearts will be randomized to receive either standard of care anti-coagulation or Actilyse® (Boehringer Ingleheim) delivered via the EKOS EkoSonic Endovascular Device. The amount of drug necessary to dissolve a blood clot is significantly reduced when using the EKOS system because ultrasound increases the permeability of the clot while gently driving the drug into its interior. We anticipate 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 their pulmonary embolism.”
Enrollment is expected to commence in Q1 2010 and be completed by Q1 2011.
About EKOS Corporation: EKOS Corporation pioneered the development and clinical application of ultrasonic accelerated drug delivery in medicine, introducing its first system for the treatment of vascular thrombosis in 2005. Today, interventional radiologists, cardiologists and vascular surgeons at leading institutions around the world use the EKOS EkoSonic® Endovascular System to provide faster, safer and more complete dissolution of thrombus. In 2008, the company introduced its 2nd generation EkoSonic® Endovascular System with Rapid Pulse™ Modulation, and in 2009 introduced the MACH4e upgrade. The EkoSonic System is FDA-cleared for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. It is currently used to treat patients with peripheral arterial occlusions (PAO) and deep vein thrombosis (DVT), and additional applications are being investigated. EKOS is currently participating in the ATTRACT trial as a supplier of one of the devices permitted for use. Visit www.ekoscorp.com.
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