Ultrasound Catheter Cleared in Europe to Treat Pulmonary Embolism
January 18, 2011 – The first endovascular device approved for the treatment of pulmonary embolism (PE) was granted CE-mark approval this week in Europe. The Ekos EkoSonic Endovascular System was originally designed and approved to dissolve blood clots in the arms and legs.
Pulmonary embolism occurs in approximately 1 million patients in Europe annually (600,000 in the United States), causing or contributing to 300,000 deaths each year. A PE is caused when a large blood clot obstructs the major blood vessels leading from the heart to the lungs. About 5 percent of PEs are massive, resulting in rapid heart failure and shock.
A large dose of clot-dissolving drug called a thrombolytic, delivered to a vein, was the only approved therapy for these patients; however, unintended bleeding, often fatal itself, is a much feared side-effect. Up to 40 percent of PE victims have less critical obstructions, often called sub-massive PE, which are currently treated with anticoagulant medication.
“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,” said professor Nils Kucher from the University Hospital of Bern, Switzerland, principal investigator of the Ultrasound Accelerated Thrombolysis of Pulmonary Embolism (ULTIMA) trial launched in 2010.
Tod Engelhardt, M.D., cardiothoracic surgeon from East Jefferson General Hospital, New Orleans, added that, ”Faster response with less thrombolytic drug means patients may recover within hours and the risk of bleeding is substantially reduced. 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."
"There are frustratingly few tools available today to help the seriously ill patient with pulmonary embolism,” said Peter Lin, M.D., vascular surgeon, Baylor College of Medicine, Houston, Texas. “Having now treated over 35 PE patients with the Ekos system within the past two years, I have adopted Ekos as our standard of care; a valuable addition to our armamentarium for pulmonary embolism."
The EkoSonic System is FDA-cleared for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
For more information: www.ekoscorp.com
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