Corporation, a BTG International group company (BTG plc (LSE:BTG)),
located in Bothell, Washington in the United States, today announced the
publication of the results of its Ultrasound Accelerated Thrombolysis of
Pulmonary Embolism (PE) trial (ULTIMA)
in the peer-reviewed journal of the American
Heart Association, CIRCULATION. The announcement was made at The
International Symposium on Endovascular Therapy (ISET)
in Miami, Florida in the United States.
The ULTIMA study is the world's first and only prospective randomized
controlled clinical trial of patients with submassive PE treated with
either standard of care intravenous anticoagulation or the EKOS
EkoSonic® Endovascular System and rt-PA (Actilyse®,
Boehringer Ingelheim). EKOS' unique technology uses ultrasound to
accelerate the action of clot-dissolving drugs. Dr. Nils Kucher,
Director of the Venous Thromboembolism Research Group at the University
Hospital in Bern, Switzerland, is the lead author and principal
investigator of the ULTIMA study.
In the ULTIMA study, patients treated with the EKOS
EkoSonic® Endovascular System demonstrated a
statistically significant reduction in right heart strain within 24
hours with no adverse effects from the catheterization, whereas the
patients treated only with the anticoagulant heparin showed no
significant improvement. In the EKOS group, the mean RV/LV ratio was
reduced from 1.28±0.19 at baseline to 0.99±0.17 at 24 hours (p<0.001);
in the heparin group,mean RV/LV ratio was 1.20±0.14 and 1.17±0.20,
respectively (p=0.31). The mean decrease in RV/LV ratio from baseline to
24 hours was 0.30±0.20 versus 0.03±0.16 (p<0.001), respectively. There
were no serious bleeding events in either group. There was one death in
the non-EKOS group within 90 days for reasons other than PE.
For PE patients at intermediate risk of bad outcomes, the ULTIMA trial
demonstrated that EKOS treatment was clinically superior to
anticoagulation with heparin alone in reversing right ventricular
dilation at 24 hours, without an increase in bleeding complications.
Dr. Barry Katzen, Medical Director, Baptist Cardiac and Vascular
Institute (Miami, FL), said, "The outcome and safety data are
compelling. This study suggests we should be employing a more aggressive
therapeutic approach to these patients with life threatening pulmonary
Dr. Victor Tapson, Professor of Medicine at Cedars-Sinai Medical Center
in Los Angeles, commented, "The ULTIMA study targets a patient
population that is under-recognized and under-treated. Findings of the
study support the role of the EKOS catheter-based technique as a
treatment option for these patients in need."
Matt Stupfel, General Manager at EKOS Corporation, added, "PE occurs in
approximately 1 million patients in Europe annually (600,000 in the US),
causing or contributing to 200,000 deaths each year." Stupfel concluded,
"The findings in this study will give hope to patients worldwide who may
face chronic pulmonary hypertension or death, if inadequately treated."
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 programmes 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® and the EKOS® logo 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
Statements of indications:
USA FDA Cleared Indications:
The EkoSonic® Endovascular Device is intended for controlled
and selective infusion of physician-specified fluids, including
thrombolytics, into the peripheral vasculature. The EkoSonic®
System is cleared for the infusion of solutions into the pulmonary
Not designed for peripheral vasculature dilation purposes. The system is
contraindicated when, in the medical judgement 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® and
MicroSonicTM products with the following indications for use:
The EkoSonic Endovascular Device, consisting of the Intelligent Drug
Delivery CatheterTM (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 MicroSonic SV Endovascular Device is intended for the controlled and
selective infusion of physician specified fluids, including
thrombolytics, into the peripheral vasculature.
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
Submassive Pulmonary Embolism (PE) definition - patients with pulmonary
embolism that have normal systemic blood pressure and confirmed heart
rt-PA - recombinant tissue plasminogen activator - a recombinant protein
involved in the breakdown of blood clots.
RV/LV ratio is the extent to which right ventricle is dilated in
relation to the left ventricle. Also known as an indicator for the right
PE occurs in approximately 1 million patients in Europe annually
(600,000 in the US), causing or contributing to 200,000 deaths each
year. (According to http://www.sirweb.org/patients/deep-vein-thrombosis/
and company internal data.)
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