FDA Clears BTG's Ekos Control Unit 4.0

February 27, 2017—BTG International announced US Food and Drug Administration 510(k) clearance for the company's Ekos Control Unit 4.0 to power the Ekos system, which is an ultrasonic device that uses acoustic pulses to dissolve blood clots and restore blood flow in patients with pulmonary embolism, deep vein thrombosis, and peripheral arterial occlusions.

According to BTG, the Ekos Control Unit 4.0 allows physicians to use one control unit to treat both pulmonary arteries. The color touchscreen allows physicians to easily monitor and independently manage two Ekos devices simultaneously, simplifying bilateral pulmonary embolism treatment. The Control Unit 4.0 features new functionality and workflow-based intelligence, said the company.

BTG describes the Ekos system as being designed to unwind and thin fibrin to expose drug receptor sites using acoustic pulses, allowing thrombolytic drugs to reach deeper into the clot, accelerating absorption and helping to dissolve the clot faster and with less thrombolytic.

In the announcement, the company cited clinical studies that have shown that the Ekos device quickens clot dissolution, increases clot removal, and enhances clinical improvement compared with either standard catheter-directed drug therapy or thrombectomy. Ekos therapy requires significantly shorter treatment times and less thrombolytic compared with standard catheter-directed drug therapy, thereby lowering the risk of bleeding and other complications, stated BTG.