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To: Popiye who wrote (14301)	6/10/1999 2:04:00 PM
From: DanielleC	Read Replies (1) \| Respond to of 15987

This one may move fast: Aegis Vortex(TM) System Will Be Clinically Evaluated at Five Centers EXTON, Pa., June 10 /PRNewswire/ -- Kensey Nash Corporation (Nasdaq: KNSY) today announced that it has received conditional approval from the US Food and Drug administration (FDA) to commence clinical trials in the US for its Aegis Vortex(TM) System, a device designed to open diseased saphenous vein grafts in patients who previously have undergone coronary bypass surgery. A feasibility study of the device is planned at five centers in the US, concurrent with a separate study at several centers in Europe. "Approval to commence clinical trials for this device is a significant milestone for Kensey Nash," said Joseph W. Kaufmann, president and CEO of Kensey Nash Corporation. "The design of the Aegis Vortex(TM) System incorporates several unique features which make the approach quite distinguishable from other technologies being used to address this market. We have chosen to address the saphenous vein graft market initially because of the sizable number of patients who might benefit from this device, which we estimate initially to be approximately 250,000 people worldwide per year." Each year, there are over 600,000 coronary artery bypass surgeries performed worldwide as treatment for coronary artery disease. Unfortunately, saphenous vein grafts, commonly used in cardiac bypass surgery, tend to become blocked within 10 years of the original surgery and pose one of the more challenging problems facing interventional cardiologists and cardiac surgeons today. The Aegis Vortex(TM) System is an interventional device designed to open diseased saphenous vein coronary bypass grafts, while minimizing the risk of embolization, a common problem with current treatment alternatives. The system incorporates a guidewire with an occlusion balloon inflated distal to the blockage, which is designed to prevent particles from going downstream during the procedure. The system uses a high speed rotating tip with a vortex action designed to impact the blockage, including blood clots and more fibrous material commonly found in vein grafts. The debris is then removed through an extraction system. Kensey Nash Corporation is a medical device company which is a leader in cardiac catheterization puncture closure devices and has platforms in absorbable biomaterials and revascularization technologies. The Angio-Seal(TM) device, developed by Kensey Nash, seals arterial punctures created during common cardiovascular catheterization procedures such as diagnostic angiography, balloon angioplasty and stenting. The device has been demonstrated to provide a safe, effective and quick method of sealing femoral arterial punctures and is designed to lower procedure costs and enhance patient comfort. The Angio-Seal is marketed worldwide by St. Jude Medical, through its Daig division. Statements contained in this press release that are not historical facts are forward-looking statements that are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. The Company cautions that a number of important factors could cause the Company's actual results to differ materially from those in the forward-looking statements including, without limitation, St. Jude Medical's ability to successfully manufacture and market the Angio-Seal, additional regulatory approvals, the Company's ability to manufacture Angio-Seal components and competition from other puncture closure devices. Results of operations in any past period should not be considered indicative of the results to be expected for future periods. Fluctuations in operating results may also result in fluctuations in the price of the Common Stock. SOURCE Kensey Nash Corporation CO: Kensey Nash Corporation ST: Pennsylvania IN: MTC SU: 06/10/99 13:38 EDT prnewswire.com