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10.8.2007
FDA Clears OmniWave™ Endovascular System for Clot Removal in Peripheral Vessels

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2.7.2011
Cybersonics Purchases the Assets of Omnisonics Medical Technologies

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What is the effect of the OmniWave™ Endovascular System on Hemolysis?
After 10 minutes of activation, the OmniWave system produces acceptable hemolysis levels that were less than 20% of the Possis AngioJet system. For further details, refer to this paper published in the Journal of Vascular and Interventional Radiology.

Does the OmniWave™ Endovascular System extract the thrombus similar to other mechanical thrombectomy devices?
The OmniWave Endovascular System uses unique, transverse ultrasound energy to dissolve the thrombus into microparticulates, over 90% of which are smaller than 10 microns.* This is unlike other mechanical devices that macerate thrombus into particulate that then requires extraction from the body, typically using a pressure-type vacuum.

How does the OmniWave™ Endovascular System selectively dissolve thrombus but not damage the delicate surrounding structures?
Similar to ultrasonic energy used in cataract surgery to dissolve the diseased tissue without damaging the delicate eye tissues, OmniWave Technology uses low-power ultrasonic energy that is directed down an interventional wire that has been tuned to dissolve thrombus. The energy generated has a unique mechanism-of-action that dissolves the fibrin matrix of the thrombus without damaging surrounding structures.

Is the OmniWave Catheter compatible with standard interventional techniques?
The OmniWave Endovascular System is designed to be utilized with a 7Fr sheath and is compatible with a 0.018" guidewire.

Is the OmniWave Endovascular System available for sale or trial?
The system is commercially available in the United States and has been cleared for the infusion of physician specified fluids, including thrombolytics, and for the removal of thrombus in the peripheral vasculature. It is contraindicated for coronary or neurovascular use. For more information, click contact.

*Supporting data on file at OmniSonics Medical Technologies, Inc.

The OmniWave™ Endovascular System is indicated for the infusion of physician specified fluids, including thrombolytics and for the removal of thrombus in the peripheral vasculature. Not for coronary or neurovascular use.

The OmniWave Endovascular System is commercially available in the United States.
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