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

News | Cath Lab

May 31, 2022 — Innovative Health, LLC, a specialty cardiology reprocessor, announced that the company has received ...

Home May 31, 2022
Home
News | Cath Lab

May 26, 2022 — The U.S. Food and Drug Administration (FDA) has recalled the Dragonfly OpStar Imaging Catheter, and has ...

Home May 26, 2022
Home
News | Cath Lab
April 25, 2022 – NewYork-Presbyterian Hudson Valley Hospital celebrated the launch of its interventional cardiology ...
Home April 25, 2022
Home
News | Cath Lab
April 18, 2022 – Royal Philips and Oulu University Hospital (Finland) have announced a strategic 10-year partnership ...
Home April 18, 2022
Home
News | Cath Lab
February 16, 2022 – Fremont Bank Foundation recently donated $750,000 to its community partner, St. Rose Hospital ...
Home February 16, 2022
Home
News | Cath Lab
February 14, 2022 — A collaborative effort between The Valley Heart and Vascular Institute’s cardiology team ...
Home February 14, 2022
Home
Sponsored Content | Videos | Cath Lab

Advancements in analytics and data visualizations are helping to streamline operations and improve productivity at cath ...

Home January 13, 2022
Home
News | Cath Lab

January 4, 2022 — The U.S. Food and Drug Administration (FDA) has authorized marketing of the first laser-based device ...

Home January 04, 2022
Home
News | Cath Lab

December 14, 2021 — RSIP Vision, a medical imaging company applying advanced artificial intelligence (AI) and computer ...

Home December 14, 2021
Home
Feature | Cath Lab

November 15, 2021 — RealView Imaging Ltd. recently received FDA 510(k) clearance for its Holoscope-i holographic system ...

Home November 15, 2021
Home
Subscribe Now