Ekos, the Bothell, WA-based maker of an ultrasound-based technology for dissolving blood clots, has won approval to market its device against life threatening clots in the lungs among patients in Europe.
The Ekosonic system, which we wrote about in these pages a year ago, has won approval from regulators in the European Union as a treatment for pulmonary embolisms. It’s the first time an endovascular device—which uses a catheter to slide inside arteries—has won approval to fight pulmonary embolisms in Europe, Ekos said.
The Ekos system was designed to treat clots in the arms and legs, and has been used frequently for deep vein thrombosis. While that’s a chronic condition, Ekos has seen an important potential market open up with pulmonary embolism, in which clots that start in another part of the body break off and flow into the lungs, where they can quickly be fatal. Pulmonary embolisms are thought to kill 300,000 people a year in the U.S. and Europe, Ekos has said.
The Ekos system is designed to work by using ultrasound waves on a catheter that gently jostle the clot, making it faster and easier for standard clot-dissolving drugs (known as thrombolytics) to do their thing. Ekos decided to go after the new market of pulmonary embolism patients after doctors urged it to move into this quite sick patient population.
“Faster response with less thrombolytic drug means patients may recover within hours and the risk of bleeding is substantially reduced,” said Dr. Tod Engelhardt, a cardiothoracic surgeon from East Jefferson General Hospital in New Orleans, in an Ekos statement.