BTG plc (LSE: BTG), the global specialist healthcare company,
today announced U.S. Food and Drug Administration 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 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 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.1
About Pulmonary Embolism
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
About the EKOS® Endovascular System
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 therapy4, 5,6, lowering the risk of bleeding
and other complications.1,6,7
Reference materials as the remarks in the press release:
1Lin, 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.
2Banovac, R et al., "Reporting standards for endovascular
treatment of pulmonary embolism." Journal of Vascular and
Interventional Radiology, 2010; 21: 44-53.
3Schrijver, 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.
4Litzendorf, 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.
5Lin, 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.
6Parikh, 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.
7Kucher, 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.
About BTG
BTG is a global specialist healthcare company bringing to market
innovative products in specialist areas of medicine to better serve
doctors and their patients. We have 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. To learn more about BTG, please
visit: btgplc.com.
EKOS is a registered trademark of EKOS Corporation, a BTG
International group company. BTG and the BTG roundel logo are
registered trademarks of BTG International LTD
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BTGHayley Senior, Media Relations Manager+44 (0)20 7575
1582; Mobile: +44 (0)7815 778 536orChris Sampson, Corporate
Communications Director+44 (0)20 7575 1595; Mobile: +44
(0)7773 251 178orGreentarget CommunicationsChris Gale, Vice
President+1-646-695-2883; Mobile: +1-203-570-4681
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