Technology | Pulmonary Embolism | March 01, 2017

BTG Receives FDA 510(k) Clearance for Ekos Control Unit 4.0

New device allows physicians to use one control unit to treat both pulmonary arteries simultaneously for pulmonary embolism

March 1, 2017 — BTG plc announced U.S. 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 (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 device is designed to support a medical team’s ability to perform at a high level – from cath lab to transport to intensive care unit.

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

For more information: www.btgplc.com

References

1. Lin, P., et al., “Comparison of Percutaneous Ultrasound-Accelerated Thrombolysis versus Catheter-Directed Thrombolysis in Patients with Acute Massive Pulmonary Embolism.” Vascular, Vol. 17, Suppl. 3, 2009, S137–S147.

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