Ekos announced that its EkoSonic has received CE mark for the treatment of pulmonary embolism on 18 January 2011. This is the first endovascular device approved for the treatment of pulmonary embolism, stated the company. The EkoSonic system was originally designed, FDA approved and CE marked to treat peripheral arterial occlusion and deep vein thrombosis.
Pulmonary embolism occurs in approximately one million patients in Europe annually (600,000 in the USA), causing or contributing to 300,000 deaths each year. The only approved therapy for these patients was a large dose of clot-dissolving drug called a thrombolytic, delivered to a vein; however, it had side-effects such us unintended bleeding. Up to 40% of pulmonary embolism victims have sub-massive pulmonary embolism, a less critical obstruction that is treated with anti-coagulant. These medications do not remove clot; they simply prevent the clot from growing larger.
Recent studies suggest that failure to remove these sub-massive clots may have long-term adverse events including recurrent pulmonary embolism, chronic pulmonary hypertension, and death. Up to 22% of these patients will die within 90 days. The EkoSonic system provides a new life saving therapy for these patients.
Nils Kucher from the University Hospital of Bern, Switzerland, principal investigator of the Ultrasound Accelerated Thrombolysis of Pulmonary Embolism (ULTIMA) trial launched in 2010, emphasised, “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”.
Tod Engelhardt, cardiothoracic surgeon from East Jefferson General Hospital, New Orleans, Los Angeles, USA added that, “Faster response with less thrombolytic drug means patients may recover within hours and the risk of bleeding is substantially reduced. I have 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.”
Peter Lin, vascular surgeon from Baylor College of Medicine, Houston, Texas, USA commented, “There are frustratingly few tools available today to help the seriously ill patient with pulmonary embolism. Having now treated over 35 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.”
“Since 2004, the Ekos system has been cleared for use by the US FDA and European authorities for use in clearing blood clots in the arms and legs. Ekos pursued CE mark for treating pulmonary embolism based on receiving positive results from physicians treating these patients with the EkoSonic system, along with several centers publishing their findings in peer reviewed journals,” Robert W. Hubert, Ekos president and CEO said.