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TMCNet:  EkoSonic® Endovascular System Receives FDA Clearance for the Treatment of Pulmonary Embolism in the USA

[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.


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 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® 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, 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.

Contraindications:

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:

Peripheral Vasculature

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.

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 arteriesĀ orĀ 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.

References:

  1. According to http://www.sirweb.org/patients/deep-vein-thrombosis/.
  2. 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. 1997;30:1165-1171.
  3. Kucher N, Rossi E, De Rosa M, Goldhaber SZ. Massive pulmonary embolism. Circulation. 2006;113:577-582.


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