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Redwood City, CA - February 16, 2007
Today, in Los Angeles, the Genesis Proximal Occlusion Funnel Catheter was used in a novel neurovascular procedure sometimes referred to as a refinement of the Dallas Maneuver. The Funnel Catheter was placed in the Internal Carotid Artery (ICA) to assist with clipping of an intracranial aneurysm. It is often necessary to reduce the pressure in an intracranial aneurysm and decompress it prior to clipping. Usually balloon catheters are used to reduce the blood pressure, but balloon catheters, by design, take time to inflate and deflate and require noteworthy force against the vessel to complete occlusion. Vessel dissections from occlusion balloons have been reported. The Genesis Funnel Catheter harnesses the patient's own blood pressure to achieve occlusion so pressure against the vessel is minimized. Additionally, the instant on/instant off mechanism of the Funnel Catheter provides immediate occlusion and reflow when required. Further, most balloon catheters are designed with an internal lumen of approximately .038", enough only to accommodate a guide wire. Because anticoagulation cannot usually be utilized in this procedure, it can be more than difficult for the physician to remove blood through this small internal lumen. The large internal lumen of the Funnel Catheter allows for easier decompression of the aneurysm.
"This is an immense problem." commented William R. Dubrul, CEO, "Unfortunately, once a rupture of the aneurysm occurs, the outcome is often poor. Genesis is extremely happy to be able to contribute to more favorable outcomes for the patient. It is what the entire Genesis team works toward. Even further, an even more ubiquitous use, similar to what we did today is a Balloon Test Occlusions (BTO's). BTO's are a very common diagnostic test for intracranial aneurysms as well as many other head and neck procedures and the Funnel Catheter may provide for a better diagnostic approach. We are hopeful that the Genesis Funnel Catheter will be beneficial in this population as well. This new market contributes to our already established coronary, carotid and peripheral markets. As the Funnel Catheter is put into interventional hands, more and more applications will be discovered."
About Cerebral Aneurysms and Clip Occlusion
Three to six million people in the United States have brain aneurysms. The incidence of subarachnoid hemorrhage from a ruptured brain aneurysm is about 12/100,000. In Japan that number increases more than three fold.
Clip Occlusion for intracranial aneurysms is the most common therapy. Both ophthalmic and carotid artery aneurysms frequently require the temporary interruption of local circulation to facilitate safe clip occlusion. Owing to the brisk retrograde blood flow, the simple trapping of the aneurysm by arterial clamping may not adequately soften the lesion. Retrograde suction/decompression aspiration of this collateral supply by a catheter is a popular method to achieve aneurysm deflation. The advent/introduction of balloon catheters allows temporary occlusion of the arteries feeding the aneurysm. Further, once the balloon is inflated, the physician applies a vacuum to the central lumen of the balloon catheter to decompress the aneurysm. Unfortunately, balloon catheters have been reported to cause vessel dissections due to the required force needed to cause occlusion.
Genesis announced its first shipment of the Funnel Catheter in late January, 2007 and already a breakthrough application has been established for this novel catheter technology.
Genesis will be exhibiting the F.A.S.T Funnel Catheter at the upcoming SIR 2007 in Seattle in early March and ACC 2007 in the end of March in New Orleans, and will provide a "wet lab" demonstrating the instant on/off occlusion feature, intuitive ease of use, the innovative funnel, and other features of the device. A complete description of the F.A.S.T Funnel Catheter can be found at http://www.genesismedical.net/html/products.html
About Genesis Medical Interventional, Inc.
Genesis Medical Interventional, Inc. (Genesis) is a privately held company developing products, based on its minimally invasive Funnel Catheter platform technologies, to remove thrombi and emboli from the vasculature. The company believes its technologies will have applications in many major medical markets. The F.A.S.T. Funnel Catheter has been cleared by the FDA via 510(k) marketing clearance and has a proven track record with over 100 peripheral and coronary clinical cases completed with excellent results.
For additional information, please contact William R. Dubrul, Genesis CEO at will@genesismedical.net or visit the Genesis website at www.genesismedical.net .
This press release contains forward-looking statements that are based upon management's current expectations and are inherently uncertain. Forward-looking statements are based upon information available to us as of the date of this press release and we assume no obligation to revise or update any such forward-looking statement to reflect any event or circumstance after the date of this release. Actual results and timing of events could differ materially from current expectations and from any forward-looking statements made by the company.
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