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TMCNet:  Pulmonary Embolism Trial Comparing Endovascular Ultrasound to Standard of Care Anticoagulation Published in the American Heart Association's Journal, Circulation

[January 20, 2014]

Pulmonary Embolism Trial Comparing Endovascular Ultrasound to Standard of Care Anticoagulation Published in the American Heart Association's Journal, Circulation

MIAMI --(Business Wire)--

EKOS 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 emboli."

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."

About BTG

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® Endovascular System

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 elsewhere.

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 arteries.

Contraindications:

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:

Peripheral Vasculature

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.

Pulmonary Embolism

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 dysfunction.

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 heart dysfunction.

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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