Bothell, WA based EKOS Corporation has announced that its EkoSonic Endovascular System has received European CE Mark approval for treatment of pulmonary embolism (PE). The device, which we covered in 2008, was previously FDA approved and CE marked for treatment of peripheral arterial occlusion and deep vein thrombosis. The EkoSonic system consists of special catheters which can deliver thrombolytic drugs to the occlusion site and emit ultrasound energy to speed up the process of breaking down the clot.
From the announcement:
Prof. Nils Kucher from the University Hospital of Bern (Switzerland), principal investigator of the Ultrasound Accelerated Thrombolysis of Pulmonary Embolism (ULTIMA) trial launched in 2010, emphasized, “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.
Dr. Tod Engelhardt, cardiothoracic surgeon from East Jefferson General Hospital (New Orleans, LA) 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."
Comany’s press statement: EKOS Corporation Receives CE Mark to Treat Massive and Sub-Massive Pulmonary Embolism…
Product page: EkoSonic Endovascular System…
Flashback: EKOS MicroSonic Accelerated Thrombolysis System…
