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News

OmniWave Endovascular System begins DVT clinical study

OmniSonics Medical Technologies : 18 March, 2008  (New Product)
OmniSonics Medical Technologies has enrolled its first patient in the Sonic I Clinical Registry, a prospective, multi-centred US registry study of the company's OmniWave Endovascular System (OES) in patients undergoing percutaneous mechanical thrombectomy of acute deep vein thrombosis (DVT).
All patients enrolled in the Sonic I are scheduled for follow-up at 30 days and 6 months following the OmniWave procedure. The first patient was enrolled by Daniel Clair, MD, chairman of Vascular Surgery at The Cleveland Clinic.

'The Cleveland Clinic is excited to participate in the Sonic I clinical trial with the OmniWave Endovascular System,' said Dr Clair. 'The OmniWave System has the potential to offer physicians an effective alternative to current pharmacological and mechanical treatments for deep vein thrombosis (DVT).'

In response to this important milestone, Richard Ganz, president and chief executive officer of OmniSonics Medical Technologies, said, 'We continue to be encouraged by the positive outcomes the first physicians are having with the OmniWave Endovascular System. Enrolling our first patient in the Sonic I Clinical Registry is a key step in our contribution to providing tools to physicians for the treatment of DVT.'

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 Medical Technologies is exhibiting the OmniWave Endovascular System at the Society for Interventional Radiology (SIR) Meeting to be held March 15 to 20, 2008 in Washington, DC, USA.

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. DVT affects approximately 2 million people in the USA every year, and acute limb ischemia affects over 250,000 people in the USA every year.
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