If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Angio-Seal Receives Approval from the FDA EXTON, Pa., Oct. 1, 1996 -- Kensey Nash Corporation (Nasdaq: KNSY) today announced that the U.S. Food and Drug Administration ("FDA") granted marketing approval for the Company's primary product, the 8 French ("8F") size Angio-Seal device. The Angio-Seal is the first product approved by the FDA which uses both a mechanical and a biochemical seal to effectively close arterial punctures following diagnostic and certain therapeutic cardiovascular catheterization procedures. The device enables a physician to seal the puncture site within minutes as compared to the current standard of care which is approximately twenty minutes of manual pressure. In the U.S. the 8F Angio-Seal is indicated for use in sealing arterial punctures 8F and smaller following balloon angioplasty and diagnostic angiography procedures. "This device benefits everyone in the healthcare system," said Joseph W. Kaufmann, president and CEO of Kensey Nash. "It provides doctors with a safe, quick, and easy method of sealing the puncture site, potentially reduces nursing care and monitoring costs and enhances patient comfort. In addition, the potential for reduced time to ambulation, early discharge and reduced complication rates attributable to the device could ultimately lower costs throughout the entire healthcare system." Developed by Kensey Nash, the Angio-Seal will be manufactured on a commercial scale and marketed by American Home Products Corporation ("AHP"). Sales of the product by Sherwood-Davis & Geck, a subsidiary of AHP, will begin immediately at clinical sites in the U.S. and a major launch is planned during the November 1996 meeting of the American Heart Association. As a result of the approval, Kensey Nash will receive a $1.05 million milestone payment from AHP, which will be recognized in the Company's first fiscal quarter ended September 30th. Cardiovascular disease is the leading cause of death in the U.S. and Europe. Each year there are over six million diagnostic and therapeutic cardiovascular catheterization procedures performed worldwide. The Company believes that the 8F Angio-Seal addresses the market for approximately 5.5 million of these punctures. A clinical study designed to expand the marketing claims related to early ambulation is currently in progress at eight sites in the U.S. and a study examining the use of the device with stents is scheduled to begin in the fall of 1996. The Angio-Seal is currently marketed in both Canada and Europe and received "CE" Mark approval from the European Economic Community, which permits marketing of the Angio-Seal in EEC member countries. To date, over 7,500 Angio-Seal devices have been sold in Europe and Canada. Kensey Nash Corporation is a medical device company focused on the development and commercialization of a line of absorbable medical devices for the sealing of arterial punctures created during cardiovascular procedures.
|
