WILMINGTON, MA October 8, 2007 - OmniSonics Medical Technologies, Inc., a developer of advanced medical devices for use in the treatment of vascular disease, announced today
that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its catheter based OmniWave" Endovascular System for the infusion of physician specified fluids, including thrombolytics, and for the removal of thrombus in the peripheral vasculature.
The OmniWave Endovascular System is based on patented OmniWave™ Technology, the first minimally invasive catheter-based technology that delivers low-power, transverse ultrasonic energy to remove thrombus quickly, safely, and effectively. Thrombus (also known as a blood clot) occurs in a number of conditions including deep vein thrombosis (DVT), when large veins are blocked and acute limb ischemia, when there is a sudden decrease of blood flow to the arteries of a limb. DVT affects approximately 2 million people in the U.S. every year, and acute limb ischemia affects over 250,000 people in the U.S. every year.
“Clearly, this is a major accomplishment for the company as we continue on track towards building a world-class enterprise that can deliver advanced medical devices to treat vascular disease,” said Richard Ganz, president and chief executive officer of OmniSonics. “The OmniWave System is designed to safely and rapidly remove blood clots in a single session. We believe that OmniWave Technology has the potential to be used in a wide range of vascular applications.”
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