A Medical Device Daily

OmniSonics Medical Technologies (Wilmington, Massachusetts), a developer of medical devices for use in the treatment of vascular disease, said that it has received FDA clearance 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 is based on OmniWave technology, the first minimally invasive catheter-based technology that delivers low-power, transverse ultrasonic energy to remove thrombus quickly, safely, and effectively. Thrombus 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 about 2 million people in the U.S. every year, and acute limb ischemia affects more than 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/CEO 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.”