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

BTG plc, a global specialist healthcare company, has received U.S. Food and Drug Administration 510(k) clearance for its 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 is 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 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
 
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
 
The EKOS system uses ultrasonic waves in combination with clot-dissolving thrombolytic drugs to effectively dissolve clots and restore healthy heart function and blood flow.
 
In clinical studies EKOS therapy has been shown to speed time to clot dissolution, increase clot removal and enhance clinical improvement compared to either standard catheter-directed drug therapy or thrombectomy.^1,3 EKOS therapy requires significantly shorter treatment times and less thrombolytic compared to standard catheter-directed drug therapy,^{4, 5,6} lowering the risk of bleeding and other complications.^1,6,7

BTG has a portfolio of Interventional Medicine products to advance the treatment of cancer, severe emphysema, severe blood clots and varicose veins, and Specialty Pharmaceuticals that help patients overexposed to certain medications or toxins. Inspired by patient and physician needs, BTG is investing to expand its portfolio to address some of today’s most complex healthcare challenges.
 
 
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.
2. Banovac, R et al., “Reporting standards for endovascular treatment of pulmonary embolism.” Journal of Vascular and Interventional Radiology, 2010; 21: 44-53.
3. Schrijver, A.M., et al., “Dutch Randomized Trial Comparing Standard Catheter-Directed Thrombolysis and Ultrasound-Accelerated Thrombolysis for Arterial Thromboembolic Infrainguinal Disease (DUET).” Journal of Endovascular Therapy 2015, Vol. 22(1):87-95.
4. Litzendorf, M E., et al., “Ultrasound-accelerated thrombolysis is superior to catheter-directed thrombolysis for the treatment of acute limb ischemia.” Journal of Vascular Surgery, Jun 2011; 53(Suppl S), p106S-107S.
5. Lin, P., et al., “Catheter-Directed Thrombectomy and Thrombolysis for Symptomatic Lower-Extremity Deep Vein Thrombosis: Review of Current Interventional Treatment Strategies.” Perspectives in Vascular Surgery and Endovascular Therapy, 2010, 22(3): 152–163.
6. Parikh, S., et al., “Ultrasound-Accelerated Thrombolysis for the Treatment of Deep Vein Thrombosis: Initial Clinical Experience.” Journal of Vascular and Interventional Radiology, Vol. 19, Issue 4, April 2008, 521–528.
7. Kucher, N., et al., “Randomized, Controlled Trial of Ultrasound-Assisted Catheter-Directed Thrombolysis for Acute Intermediate-Risk Pulmonary Embolism.” Circulation, Vol. 129, No. 4, 2014, 479–486.