Possis Medical's Rapid Exchange Catheter Receives U.S. Coronary Labeling; XMI-RX Also Receives CE Mark, Allowing Marketing Launch at Euro PCR Meeting.Business Editors/Health/Medical Writers Paris Course on Revascularization MINNEAPOLIS--(BUSINESS WIRE)--May 13, 2004 Possis Medical, Inc. (Nasdaq:POSS), today reported that it has received approval from the U.S. Food & Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) to market the rapid exchange version of its popular XMI (1) (XML Metadata Interchange) An XML-based representation of a UML model. XMI is used to transfer UML diagrams between various modeling tools. See UML. (2) An earlier high-speed bus from Digital that was used in large VAX machines. (R) Rheolytic(TM) Thrombectomy thrombectomy /throm·bec·to·my/ (throm-bek´tah-me) surgical removal of a clot from a blood vessel. throm·bec·to·my n. Excision of a thrombus. Catheter--the XMI-RX--for coronary indications. The XMI-RX had previously been labeled for peripheral arterial use, and the new FDA approval came in response to the Company's PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy supplement. The Company also announced that it has received CE mark approval, allowing coronary marketing of the product in the European Community. Possis Medical, Inc. plans to launch the new, CE-marked product at the upcoming Paris Course on Revascularization (PCR PCR polymerase chain reaction. PCR abbr. polymerase chain reaction Polymerase chain reaction (PCR) ) to be held from May 25-28th, 2004. PCR is among the most prominent medical-scientific symposia for interventionalists in Europe, and it draws hundreds of physicians from around the globe. The Company has a number of physician presentations planned for PCR, including a case review session led by Dr. Jeffrey Popma on Thursday, May 27th. AngioJet(R) XMI case reviews from the Thoraxcentre (Rotterdam, The Netherlands) and Careggi Hospital (Florence, Italy) will discuss thrombectomy and stenting for reperfusion re·per·fu·sion n. The restoration of blood flow to an organ or tissue that has had its blood supply cut off, as after a heart attack. in acute myocardial infarction acute myocardial infarction (  ·kyōōtˑ mī·ō·karˑ·dē· . For information on PCR, please go to www.europcr.com. Robert G. Dutcher, Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Possis Medical, Inc. said, "We expect that the U.S. coronary approval of the XMI-RX will allow us to better position our product with physicians, leading to increased market acceptance. Also, the rapid-exchange platform is very important to our European physicians, and we believe that launching this new product at such a prominent European course will give our international distributors great visibility with their customers." Possis Medical, Inc., develops, manufactures and markets medical devices for the cardiovascular and vascular treatment markets. Its primary product, the AngioJet(R) Rheolytic(TM) Thrombectomy System, is marketed in the US for blood clot removal from coronary arteries, bypass grafts, leg arteries and AV dialysis access grafts. For more information about Possis, please visit www.possis.com. Certain statements in this press release, such as those referring to the market acceptance of the coronary labeled XMI-RX product and potential related sales of the AngioJet System, constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. A discussion of the factors that could impact the Company's future results are set forth in the cautionary statements included in Exhibit 99 to the Company's Form 10-K for the year ended July 31, 2003, filed with the Securities and Exchange Commission. |
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