EkoSonic Device Receives CE Mark Approval to Treat Pulmonary Embolism
January 17, 2011—Ekos Corporation (Bothell, WA) announced that the company’s EkoSonic endovascular system received CE Mark approval for the treatment of pulmonary embolism (PE) in Europe. The Ekos system was approved in the United States and Europe in 2004 for dissolving blood clots in the arms and legs.
As reported in Endovascular Today in January 2010, the company is conducting the ULTIMA (Ultrasound Accelerated Thrombolysis of Pulmonary Embolism) trial, with the objective to show that treatment with low-dose, ultrasound-accelerated thrombolysis with the EkoSonic will rapidly improve right-sided heart failure patients without introducing the risk of bleeding complications. Professor Nils Kucher, MD, is the principal investigator of the ULTIMA trial.
“Because the Ekos system incorporates into the catheter body small ultrasound transmitters, which condition the clot to more rapidly absorb the thrombolytic drug, it can dissolve the clot faster than thrombolytic drug alone,” commented Professor Kucher. “Faster response with less thrombolytic drug means patients may recover within hours, and the risk of bleeding is substantially reduced.”
Peter Lin, MD, stated, “There are frustratingly few tools available today to help the seriously ill patient with pulmonary embolism. Having now treated over 35 PE patients with the Ekos system within the past 2 years, I have adopted Ekos as our standard of care—a valuable addition to our armamentarium for pulmonary embolism."
Tod Engelhardt, MD, added, “I've treated 30 patients with the Ekos system. All have done remarkably well, and I know we have saved lives. The patients treated were all in serious condition and within a few hours of commencing treatment were asymptomatic.”