February 27, 2017 LONDON--(BUSINESS WIRE)--BTG plc (LSE: BTG), the global specialist healthcare company, today announced U.S. Food and Drug Administration 510(k) clearance has been granted to the EKOS® Control Unit 4.0. The EKOS® system includes an ultrasonic device that uses acoustic pulses, powered by the new Control Unit 4.0, to quickly and safely dissolve blood clots and restore blood flow in patients with pulmonary embolism (PE), deep vein thrombosis (DVT), and peripheral arterial occlusions (PAO).

The EKOS® Control Unit 4.0 was specifically designed to support a new standard of PE treatment – allowing 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 PE treatment. With new functionality and workflow-based intelligence, the EKOS® Control Unit 4.0 is designed to support a medical team’s ability to perform at a high level – from cath lab to transport to intensive care unit.

“Currently the only device cleared for the treatment of pulmonary embolism, EKOS® has been in a leadership position in the PE treatment market since the beginning” said BTG Vice President and General Manager Matt Stupfel. “Now, BTG is further solidifying our leadership position with the EKOS® Control Unit 4.0. This new platform will allow for further device innovation to simplify treatment for clinicians and improve outcomes for patients.”
Blood clots are tightly bound together in a fibrous mesh called fibrin. Fibrin blocks the flow of thrombolytic drugs, requiring higher drug doses to effectively dissolve the clot. The EKOS® system uses acoustic pulses to unwind and thin fibrin to expose drug receptor sites, allowing the drug to reach deeper into the clot, accelerating absorption and helping to dissolve the clot faster and with less thrombolytic.1


About Pulmonary Embolism
Pulmonary Embolism (PE) is a condition where one or more clots break off or travel from existing venous clots in the legs or arms and travel in the circulation, getting trapped in the lung, where they block the ability for blood to get to some areas of the lungs and receive oxygen. This may lead to a strain on the heart’s ability to pump blood through the lungs which can then lead to heart failure and/or cardiovascular collapse. PEs can be immediately fatal, but if PE can be diagnosed and appropriate therapy started, the mortality can be reduced from approximately 30 percent to less than 10 percent.2

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