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.

Related Content

Shockwave Initiates U.S. Pivotal Study for Coronary Intravascular Lithotripsy
News | Cath Lab | January 16, 2019
Shockwave Medical Inc. has initiated its U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE...
National Academy of Engineering, Ohio University Award 2019 Russ Prize
News | Cath Lab | January 03, 2019
Ohio University and the National Academy of Engineering announced the 2019 Fritz J. and Dolores H. Russ Prize will be...
Videos | Cath Lab | January 03, 2019
This is walk through inside one of the cardiac hybrid cath labs at the...
Videos | Cath Lab | January 03, 2019
This is the newest cardiac cath lab at the ...
Study Finds Effective Treatment for Coronary Slow Flow
News | Cath Lab | December 27, 2018
Patients who arrive at the hospital with heart-attack-like symptoms have had little recourse for their chest pain if...
Shockwave Announces Collaboration With Abiomed on Physician Training
News | Cath Lab | December 14, 2018
Shockwave Medical announced a new investment and collaboration agreement with Abiomed Inc. As outlined by the agreement...
Sponsored Content | Videos | Cath Lab | October 24, 2018
Michael Flaherty, M.D., discusses a study published in Circulation Research which finds that use of hemodynamic suppo
Philips Showcases Integrated Solutions for Cardiovascular Care at TCT 2018
News | Cath Lab | September 20, 2018
At the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting, Sept. 21–25 in San Diego, Philips is showcasing...
Overlay Init