EKOS Initiates a Pivotal New Study

Bothell, WA, 11 June 2014

EKOS Corporation, a BTG International group company (BTG plc; LSE: BTG), today announces the start of patient enrollment for the ACCelerated ThrombolySiS for Post-Thrombotic Syndrome using the EKOS System (ACCESS PTS) Study.

Deep Vein Thrombosis (DVT) is a common medical condition affecting 600,000 people annually in the United States.1 The most common complication of DVT is Post-Thrombotic Syndrome (PTS), which can affect from 25% to 60% of individuals suffering DVT.2 Despite traditional anticoagulation and elastic compression stocking therapy, a significant proportion of DVT becomes chronic with post-thrombotic sequelae which impose significant limitations to a patient’s quality of life.3,4

The ACCESS PTS study is a prospective, single-arm, multi-center trial, designed to evaluate the safety and efficacy of ultrasound accelerated thrombolysis using the EkoSonic Endovascular System with standard infusion of a thrombolytic drug for PTS and chronic venous occlusions. The study will enroll up to 200 subjects over a period of 12 months at approximately 30 study sites across the United States. Subjects will receive clinical follow-up for 12 months.

Clinical effectiveness will be evaluated using the Villalta score (measurement of the severity of PTS) at baseline compared to 30 days post-EkoSonic treatment. Success will be defined by 50% or more of the subjects achieving at least a 4 point reduction in the Villalta score, which represents a significant improvement in the symptoms of PTS.

Mark Garcia, MD, Medical Director, Center for Comprehensive Venous Health at Christiana Care in Newark, DE and the lead investigator of the study states, “This is an incredibly exciting time as we embark on a truly landmark trial that may not only alter the way physicians treat patients with chronic DVT, but also give hope to all those suffering from PTS while significantly improving their quality of life.” 

Matt Stupfel, General Manager at EKOS Corporation, also commented, “We are pleased to announce that the ACCESS PTS study is open for patient enrollment. We hope this study will demonstrate that new and innovative technologies like the EkoSonic Endovascular System can effectively treat these patients in cases where traditional exercise, anticoagulation drugs and compression stockings have been deemed inadequate.” 

Potential study subjects will be between 18 and 75 years of age with lower extremity DVT who have:

  • Been objectively diagnosed via imaging as having persistent DVT for at least 6 months
  • A Villalta score ≥8.
  • Failed 3 months of conservative treatment including compression stockings and anticoagulation drugs

If you are a physician treating a patient that meets the study criteria, please email ekosclinical@ekoscorp.com to learn more about the study and whether or not your patient may qualify.

For further information please contact:

 

BTG

Ashley Tapp, Communications Manager

+44 (0)20 7575 1513; Mobile: +44 (0)7790 811554

(For European media inquiries)

 

Greentarget Communications

Chris Gale, Vice President

+1.646.695.2883; Mobile: +1.203.570.4681

(For US trade and media inquiries

 

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, 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 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 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 arteries or lobar pulmonary arteries, and evidence of right heart dysfunction based on right heart pressures (mean pulmonary artery pressure = 25mmHg) or echocardiographic evaluation.

References:

  1. According to http://www.sirweb.org/patients/deep-vein-thrombosis/
  2. Ashrani AA, Heit JA. Incidence and cost burden of post-thrombotic syndrome. J Thromb Thrombolysis. 2009;28:465-476.
  3. Kahn SR, Shbaklo H, Lamping DL, Holcroft CA, Shrier I, Miron MJ, Roussin A, Desmarais S, Joyal F, Kassis J, Solymoss S, Desjardins L, Johri M, Ginsberg JS. Determinants of health-related quality of life during the 2 years following deep vein thrombosis.. J Thromb Haemost. 2008 Jul;6(7):1105-12. doi: 10.1111/j.15387836.2008.03002.x. Epub 2008 Jun 1.
  4. vanKorlaar IM, Vossen CY, Rosendaal FR, Bovill EG, Cushman M, Naud S, Kaptein AA. The impact of venous thrombosis on quality of life. Thromb Res. 2004; 114 (1):11-8.