Thirty-Seven Patients Treated With Ultrasound Accelerated Catheter Direct Pharmacological Thrombolysis

At the 35th Annual VEITHsymposium (New York, NY), Karthikeshwar Kasirajan, MD, Assistant Professor of Surgery, Emory University School of Medicine, The Emory Clinic (Atlanta, Georgia) is presenting data on 37 patients treated with catheter-direct pharmacological thrombolysis using recombinant tissue plasminogen activator via the EKOS infusion system.

The study was conducted from December 2006 to August 2008. The purpose of the study was to evaluate the safety and efficacy of ultrasound as an adjunct to facilitate pharmacological thrombolysis.

Robert W. Hubert, President/CEO of EKOS Corporation commented that, “Dr. Kasirajan’s study is consistent with the recently published article by Dr. Sanjiv Parikh, et. al. in the April publication of JVIR which reported EKOS-treated patients received half the thrombolytic drug dose or were treated in half the time, or both, when compared to recent historical experience with standard non-ultrasound catheter directed thrombolysis (CDT). Additionally, the Kasirajan and Parikh studies were generated with our first generation product. Our newest product, the EkoSonic Mach 4, which was released to the market late July 2008 promises to perform even faster; up to 4x faster than standard CDT based on extensive in-vitro data of published this month by Dr. Soltani et. al. in Physics in Medicine and Biology. Using the Mach 4, we already have case reports of complete DVT resolution in less than 6 hours. The Mach 4, like our earlier generation product, often dissolves clot out to the vessel wall including clot formed behind the valves. Unlike mechanical devices, the EKOS products have a high percentage of complete thrombus resolution, do not create hemolysis and present a low risk of distal embolization. Clearly EKOS is setting a new standard of clot removal in the peripheral vasculature.”

SIDEBAR:

Venous thromboembolism and chronic venous insufficiency continue to be associated with high mortality and major morbidity in the United States. Each year over 700,000 patients in the US develop blood clots (thrombus) in the arteries (peripheral arterial occlusions or PAO) and veins (deep vein thrombosis or DVT) of their arms or legs. Often the clot resolves itself or can be treated with medication, e.g., blood thinners. However, because blood thinners prevent but do not actively remove clot, many DVT patients treated with blood thinners alone develop Post Thrombotic Syndrome (PTS). This condition is thought to result from damage to the delicate venous valves when exposed to the occluding blood clot for time periods greater than a few weeks. PTS can subsequently develop over months or years into a serious irreversible debilitating condition. Thus, many physicians are now performing interventional treatments such as the EKOS procedure to remove as much of the clot as possible immediately after diagnosis of significant DVT. The recently published American College of Chest Physicians (ACCP) guidelines include sections containing suggestions for antithrombotic/thrombolytic therapy for DVT. The new Guidelines align closely with the benefits of the EKOS MicroSonic™ Accelerated Thrombolysis (MSAT), and should allow physicians to confidently refer patients with acute DVT and PAO for treatment. Guidelines can be found at http://www.chestjournal.org/cgi/reprint/133/6_suppl/71S .

About EKOS Corporation

EKOS Corporation pioneered the development and clinical application of microsonic technologies in medicine, introducing its first system for the treatment of vascular thrombosis in 2005. Today, interventional radiologists, cardiologists and vascular surgeons at leading institutions across the nation use EKOS MicroSonic™ Accelerated Thrombolysis (MSAT) to provide faster, safer and more complete dissolution of thrombus. In 2008, the company introduced the 2nd generation EkoSonic™ Endovascular System with Rapid Pulse™ Modulation. The EkoSonic System is FDA-cleared for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. It is currently used to treat patients with peripheral arterial occlusions (PAO) and deep vein thrombosis (DVT) and additional applications are being investigated. Visit www.ekoscorp.com

About VEITHsymposium

Now in its fourth decade, VEITHsymposium™ provides vascular surgeons, interventional radiologists, interventional cardiologists and other vascular specialists with a unique and exciting format to learn the most current information about what is new and important in the treatment of vascular disease. The 5-day event features over 400 rapid-fire presentations from world-renowned vascular specialists with emphasis on the latest advances, changing concepts in diagnosis and management, pressing controversies and new techniques. Press registration details can be found at www.VEITHpress.org. VEITHsymposium is sponsored by Cleveland Clinic (Cleveland, OH).