BTG has announced US Food and Drug Administration (FDA) 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, deep vein thrombosis, and peripheral arterial occlusions.
The EKOS Control Unit 4.0 was specifically designed to support a new standard of pulmonary embolism treatment, allowing physicians to use one control unit to treat both pulmonary arteries. The colour touchscreen allows physicians to easily monitor and independently manage two EKOS devices simultaneously, simplifying bilateral pulmonary embolism 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 pulmonary embolism 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.