WILMINGTON, Mass., May 12 /PRNewswire/ -- OmniSonics Medical Technologies, Inc., a developer of advanced medical devices for use in the treatment of vascular disease, announced today that it has enrolled its first patient in the SONIC II REGISTRY. SONIC II is a prospective, multi-center U.S. registry study of the company's OmniWave(TM) Endovascular System (OES) in patients undergoing percutaneous mechanical thrombectomy for acute limb ischemia (ALI). All patients enrolled in the SONIC II REGISTRY are scheduled for follow-up at 30 days, 6 months, and 1 year following the OmniWave procedure. The first patient was enrolled at the Midwest Institute for Minimally Invasive Therapies (MIMIT) in Chicago, IL, by Paramjit (Romi) Chopra, M.D.
"The SONIC II REGISTRY is an important collaboration between OmniSonics and healthcare professionals treating acute limb ischemia to bring innovative treatments to patients suffering from such a disabling disease. We are proud to be in a position to contribute clinical data to such a valuable study," said Paramjit (Romi) Chopra M.D., Director for the MIMIT.
Richard Ganz, President and CEO of OmniSonics Medical Technologies, said, "The initiation of the SONIC II REGISTRY is an important strategic development in OmniSonics' continuation of a strong clinical program to support the OmniWave Endovascular System as a therapy for treating patients with ALI. We are excited about the enthusiasm that the physician community has expressed for this technology and its future potential applications in clinical practice."
In September 2007, OmniSonics received clearance from the 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. OmniSonics is also currently collecting data in the SONIC I REGISTRY of the company's OmniWave Endovascular System in patients undergoing percutaneous mechanical thrombectomy of acute deep vein thrombosis (DVT).
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) and acute limb ischemia (ALI). 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.
About OmniSonics Medical Technologies, Inc.
OmniSonics Medical Technologies, Inc., based in Wilmington, MA, is a
venture-backed medical device company focused on developing breakthrough
products for the treatment of vascular disease. The Company's products are
based on its patented OmniWave technology, the first technology capable of
delivering low-power ultrasonic energy around the active length of a small
diameter wire in a diseased blood vessel. OmniWave technology is designed
to have broad applications in vascular disease.
Contact: Len Farris
Vice President, Marketing
(978) 657-9980 x501
|SOURCE OmniSonics Medical Technologies, Inc.|
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