The OmniCath Atherectomy Catheter
The OmniCath is an "atherectomy catheter," designed to allow physicians to remove atherosclerotic plaque from obstructed blood vessels throughout the body, thereby enlarging vessels narrowed by plaque, increasing a patient's blood flow. This is accomplished by removing the plaque with a cutting device, leaving the vessel wall, depending on technique, clean and smooth, free of fissures, ruptures and flaps The Company is developing the OmniCath with catheter shafts of several different diameters for use in coronary arteries which feed the heart (5.8 to 7 French) and in peripheral arteries in the abdomen, groin and legs (7 French and 8 French). "French" is a measure of diameter, one French is equivalent to 1/3rd of a millimeter.
The OmniCath, powered by a small battery pack and motor assembly in its handle, is self-contained and disposable. Connected to the handle is the catheter shaft which will vary in length depending on the distance needed from insertion to the treatment site. The weight of the OmniCath is approximately 11 ounces.
The OmniCath's shaft has a side-window and a small rotating cylindrical blade near its distal end (the end of the catheter or furthest part of the catheter which is inserted into the body). At the surface opposite the side-window are two deflector wires which, when advanced against the arterial wall opposite the plaque using controls in the handle, stabilize the catheter shaft and allow the window to cover a larger volume of the plaque, compressing it into the path of the rotating blade. Once the deflector wires are engaged and the side window is in position, using controls on the OmniCath handle, the rotating blade can be advanced and retracted across the side-window at approximately 11,000 RPM to shave the atherosclerotic plaque from the interior surface of the vessel walls. The blade does not come into contact with the non-diseased arterial walls during the atherectomy procedure. The shaved plaque is aspirated into an annular space in the catheter and evacuated through a removal port at the proximal end of the catheter (the end at the OmniCath handle) via a vacuum system. This enables the excised plaque to be collected and examined while the atherectomy is taking place. There is minimal blood loss during the procedure as the OmniCathr is designed to restrict the amount of blood which enters the catheter system. Further, the blockage of blood circulation by an inflated balloon, which often occurs in balloon angioplasty, does not occur in a procedure using the OmniCath. This is due to the design of the deflectable system, which allows continuous blood flow while holding the catheter in place.
Overall, the OmniCath is designed for ease of use and provide the physician the capability of multiple lesion atherectomy procedures with a single placement, as opposed to the multiple placements often required with balloon angioplasty and competitive atherectomy devices. The OmniCath's features, including its lightweight and compact construction are designed to provide a competitive advantage over existing atherectomy catheters. See "Item 1 - Business - Competition."
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Regards, Jeff |