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Redwood City, CA -- March 23, 2006
Genesis Medical Interventional, Inc. (Genesis), a developer of novel, minimally invasive, vascular interventional tools for occlusive vascular disease, announced today the completion its OUS clinical trial for its flagship F.A.S.T.™ Funnel Catheter™ for Proximal Occlusion Embolic Protection. The company believes that the F.A.S.T.™ Funnel Catheter™ will prevent and reduce embolic events associated with Percutaneous Coronary Interventions (PCI's), affecting millions of people annually.
The F.A.S.T.™ Funnel Catheter™ system was used in coronary lesions where PCI's were being performed. The trial was accomplished via ethics approved protocols in New Zealand, Germany, Holland and Poland at five separate hospitals. More than nine different cardiologists used the device during the trial which was co-led by study principal investigators Drs. Mark Webster in Auckland, Dougal McClean in Christchurch, Horst Sievert in Frankfurt, Dariusz Dudek in Krakow and Hans Bonnier and Jacques Koolen in The Netherlands. The study examined acute and 30 day outcomes when the F.A.S.T.™ Funnel Catheter™ was used for Proximal Occlusion Embolic Protection.
"The F.A.S.T.™ Funnel Catheter™ is a promising new approach to embolic protection and potentially a valuable adjunct to the treatment of all PCI's. We believe it has the potential to improve outcomes in more than half of the 2.2 million coronary angioplasties performed annually worldwide." said William Dubrul, Genesis CEO.
The F.A.S.T.™ Funnel Catheter™ is and Instant On / Instant Off, proximally occluding funnel catheter that stops blood flow temporarily while interventions are being performed. The device uses the patient's own blood pressure and a funnel on the distal end of the catheter to achieve occlusion in contrast to balloon and filter devices from competitors such as St. Jude, ev3, Boston Scientific, JnJ Cordis, Medtronic and others.
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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