|[May 23, 2014]
EkoSonic® Endovascular System Receives FDA Clearance for the Treatment of Pulmonary Embolism in the USA
BOTHELL, Wash. --(Business Wire)--
23 May 2014: EKOS Corporation, a BTG International group company
(BTG plc (LSE: BTG)), today announced that the U.S. Food and Drug
Administration (FDA) has cleared the EkoSonic® Endovascular
System for the ultrasound facilitated, controlled and selective infusion
of physician-specified fluids, including thrombolytics, into the
vasculature for the treatment of pulmonary embolism (PE).
The EKOS® ultrasonic devices are designed to gently
accelerate the penetration of thrombolytic agents into thrombus,
providing high levels of lysis. EKOS® is the only minimally
invasive endovascular therapy on the market that has been FDA cleared
for the treatment of PE.
PE occurs in approximately 600,000 patients in the US, causing or
contributing to 200,0001 deaths each year. PE also causes or
contributes to 15%2,3 of all hospital deaths. Samuel Z.
Goldhaber, MD, Professor of Medicine, Harvard Medical School and
Director, Thrombosis Research Group, Brigham and Woman's Hospital
(Boston, MA), said, "The EKOS® clinical data established that
patients stricken with a life-threatening pulmonary embolism can be
successfully and safely treated with the EkoSonic® system.
This is the first FDA cleared treatment option for PE since the approval
of the drug, tPA, in 1990."
"Interventional radiologists, cardiologists, cardiothoracic and vascular
surgeons at leading institutions around the world use our system to
provide faster, safer and more complete dissolution of thrombus,"
commented Matt Stupfel, General Manager of EKOS. "We are proud to have
completed the world's only randomized controlled trial (ULTIMA) and the
largest prospective single-arm trial (SEATTLE II) on the safety and
effectiveness of EKOS® therapy in the treatment of PE. The
positive outcomes of those trials, combined with our expanded indication
will allow a better standard of care for thousands of patients who
suffer from PE."
In January of 2014, the outcomes of ULTIMA were published in American
Heart Association's Journal, Circulation. The trial demonstrated
that for PE patients at intermediate risk of adverse events, EKOS®
treatment was clinically superior to anticoagulation with heparin alone
in reversing right ventricular dilation at 24 hours, without an increase
in bleeding complications.
Following ULTIMA, the results of SEATTLE II, the prospective single-arm
multi-center trial of 150 patients, were released at this year's
American College of Cardiology. SEATTLE II trial demonstrated that
ultrasound-facilitated catheter-directed low-dose fibrinolysis for acute
PE minimizes the risk of intracranial hemorrhage, improves RV function,
and decreases pulmonary hyprtension.
BTG is a growing international specialist healthcare company that is
developing and commercialising products targeting acute care, cancer and
vascular diseases. The company has diversified revenues from sales of
its own marketed products and from royalties on partnered products, and
is seeking to acquire new programs and products to develop and market to
specialist physicians. To find out more about the BTG International
group companies and our products, visit www.btgplc.com.
About EKOS Corporation and the EkoSonic®
EKOS Corporation, a BTG International group company, pioneered the
development and clinical application of ultrasound infusion technologies
in medicine, introducing its first system for the treatment of vascular
thrombosis in 2005. Today, interventional radiologists, cardiologists,
cardiothoracic and vascular surgeons at leading institutions around the
world use the EKOS EkoSonic® Endovascular System to provide
faster, safer and more complete dissolution of thrombus. To find out
more about the EKOS EkoSonic® Endovascular System, visit www.ekoscorp.com.
EKOS, EkoSonic, and MicroSonic are the trademarks of EKOS Corporation, a
BTG International group company. BTG and the BTG roundel are registered
trademarks of BTG International Ltd in US, EU and certain other
territories and trademarks of BTG International Ltd elsewhere.
Statements of indications:
USA FDA Cleared Indications:
The EkoSonic® Endovascular System is intended for controlled
and selective infusion of physician-specified fluids, including
thrombolytics, into the peripheral vasculature. The EkoSonic®
Endovascular System is intended for the infusion of solutions into the
pulmonary arteries. The EkoSonic® Endovascular System is
indicated for the ultrasound facilitated, controlled and selective
infusion of physician-specified fluids, including thrombolytics, into
the vasculature for the treatment of pulmonary embolism.
Not designed for peripheral vasculature dilation purposes. The system is
contraindicated when, in the medical judgment of the physician, such
procedure may compromise the patient's condition. See device
instructions for use for complete prescribing information.
The CE Mark (CE0086) has been affixed to the EkoSonic®
product with the following indications for use:
The EkoSonic® Endovascular Device, consisting of the
Intelligent Drug Delivery Catheter (IDDC) and the MicroSonic™
Device (MSD), is intended for controlled and selective infusion of
physician-specified fluids, including thrombolytics, into the peripheral
vasculature. All therapeutic agents utilized with the EkoSonic®
Endovascular System should be fully prepared and used according to the
instruction for use of the specific therapeutic agent.
The EKOS EkoSonic® Endovascular System is intended for the
treatment of pulmonary embolism patients with = 50% clot burden in one
or both main pulmonary arteries or lobar pulmonary arteries, and
evidence of right heart dysfunction based on right heart pressures (mean
pulmonary artery pressure = 25mmHg) or echocardiographic evaluation.
Notes to Editors
Pulmonary embolism is a sudden blockage in a lung artery. The blockage
usually is caused by a blood clot that travels to the lung from a vein
in the leg.
Right ventricular dilation is the extent to which right ventricle is
dilated in relation to the left ventricle. Also known as an indicator
for the right heart dysfunction.
Pulmonary hypertension is increased pressure in the pulmonary arteries.
These arteries carry blood from heart to lungs to pick up oxygen. It
causes symptoms such as shortness of breath during routine activity,
tiredness, chest pain, and a racing heartbeat.
According to http://www.sirweb.org/patients/deep-vein-thrombosis/.
Kasper W, Konstantinides S, Geibel A, Olschewski M, Heinrich F,
Grosser KD, Rauber K, Iversen S, Redecker M, Kienast J. Management
strategies and determinants of outcome in acute major pulmonary
embolism: Results of a multicenter registry. J Am Coll Cardiol.
Kucher N, Rossi E, De Rosa M, Goldhaber SZ. Massive pulmonary
embolism. Circulation. 2006;113:577-582.
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