EKOS Initiates a Pivotal New Study in Patients with Chronic Deep Vein Thrombosis and Post-Thrombotic Syndrome

ACCESS PTS study aims to evaluate the safety and efficacy of Ultrasound Accelerated Thrombolysis with standard thrombolytic infusion for treatment of Post-Thrombotic Syndrome
 
Bothell, WA, USA, June 11 2014: EKOS Corporation, a BTG International group company, 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.
 
 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.1538-7836.2008.03002.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.
 

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.