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Product Offers Promise of Improved Postoperative Outcomes and Quality of Life
Redwood City, CA -- September 24, 2005
Genesis Medical Interventional, Inc. (Genesis) today announced the commencement of its Safety and Efficacy Pilot trial for the F.A.S.T.™ Funnel Catheter™ in Proximal Occlusion Embolic Protection. Genesis believes that the F.A.S.T.™ Funnel Catheter™ will prevent and reduce embolic events that are associated Percutaneous Coronary Interventions (PCI's), which affect millions of people annually.
The first procedure in the F.A.S.T.™ Trial was performed September 23, 2005 by Mark Webster, MD, at Auckland City Hospital in Auckland, New Zealand. Dr. Webster is considered an expert in the treatment PCI's in New Zealand. Dr. Webster states: "Based on this First in Man/Woman use, we are excited to continue to use F.A.S.T.™ as we enroll more patients."
Emboli are almost always liberated during stent placement and other vascular procedures. They can be very dangerous if not removed. There have been significant efforts to develop 'filters' that are placed 'downstream' before the procedure, but emboli can be liberated during the crossing of the lesion with these filters. Proximal Occlusion Embolic Protection like the F.A.S.T.™ system protects while initially crossing the lesion, during the actual intervention and during removal of the interventional tools. Genesis estimates that the potential market for embolic and thromboembolic management is over $1 billion.
"Based on this first use and our pre-clinical work, we are hopeful that F.A.S.T.™ will become the product of choice for cardiologists to prevent embolic proliferation," stated William Dubrul, President and CEO of Genesis Medical Interventional, Inc. "This uniquely simple Funnel Catheter, offers interventionalists what they have been lacking in previous products; the ability to simply and quickly occlude and un-occlude the vessel. We are excited to begin this multi-center trial as a step towards bringing F.A.S.T.™ to market."
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 Genesis F.A.S.T.™ Funnel Catheter™ system is a simple funnel catheter that occludes blood flow and stops blood pressure prior to entering the interventional site. Before entering the lesion with even a small guide wire, the Genesis F.A.S.T.™ Funnel Catheter™ system temporarily occludes proximally with the funnel catheter . By temporarily stopping blood flow, emboli that are loosened cannot travel downstream because there is no downstream. The funnel gently deploys against the inner wall of the vessel using the patient's own blood pressure to create the occlusion in the vessel. The device also allows the physician to use the funnel to remove emboli and thrombi from the treated vessel by using simple aspiration from a syringe.
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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