-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, FLyCkl5QUZGnhlxxh9QPMU27d/+o5CNKQqU5UrY8oMIDXY9gpnrOFP1obt4/1W2q l0yZEk+c98uwofXetObD0Q== 0001072613-04-000562.txt : 20040309 0001072613-04-000562.hdr.sgml : 20040309 20040309172152 ACCESSION NUMBER: 0001072613-04-000562 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20040304 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20040309 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BOSTON SCIENTIFIC CORP CENTRAL INDEX KEY: 0000885725 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 042695240 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-11083 FILM NUMBER: 04658168 BUSINESS ADDRESS: STREET 1: ONE BOSTON SCIENTIFIC PL CITY: NATICK STATE: MA ZIP: 01760-1537 BUSINESS PHONE: 5086508000 8-K 1 form8-k_12542.txt BOSTON SCIENTIFIC CORPORATION FORM 8-K ================================================================================ UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ---------------- FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of report (Date of earliest event reported): March 4, 2004 BOSTON SCIENTIFIC CORPORATION ----------------------------- (Exact name of registrant as specified in charter) DELAWARE 1-11083 04-2695240 - --------------- ----------- ------------- (State or other (Commission (IRS employer jurisdiction of file number) identification no.) incorporation) ONE BOSTON SCIENTIFIC PLACE, NATICK, MASSACHUSETTS 01760-1537 -------------------------------------------------- ---------- (Address of principal executive offices) (Zip code) Registrant's telephone number, including area code: (508) 650-8000 ================================================================================ ITEM 5. OTHER EVENTS AND REQUIRED FD DISCLOSURE. On March 4, 2004, Boston Scientific Corporation (the "Company") issued a press release announcing that it received approval from the United States Food and Drug Administration to market its TAXUS(TM) Express(2)(TM)paclitaxel- eluting coronary stent system in the United States. A copy of the release is attached to this report as exhibit 99.1. ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS (c) Exhibits. 99.1 Press Release issued by the Company dated March 4, 2004. SIGNATURES Pursuant to the requirements of the Securities and Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. BOSTON SCIENTIFIC CORPORATION Date: March 9, 2004 By: /s/ Lawrence J. Knopf -------------------------------------------- Lawrence J. Knopf Vice President and Assistant General Counsel EX-99.1 3 exh99-1_12542.txt PRESS RELEASE DATED MARCH 4, 2004 EXHIBIT 99.1 ------------ NEWS FOR IMMEDIATE RELEASE - -------------------------------------------------------------------------------- [LOGO] BOSTON SCIENTIFIC Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 508.650.8000 www.bostonscientific.com BOSTON SCIENTIFIC ANNOUNCES FDA APPROVAL FOR ITS TAXUS(TM) EXPRESS(2)(TM) PACLITAXEL-ELUTING CORONARY STENT SYSTEM COMPANY PLANS TO LAUNCH IN U.S. IMMEDIATELY Natick, MA (March 4, 2004) - Boston Scientific Corporation (NYSE: BSX) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market its TAXUS(TM) Express(2)(TM) paclitaxel-eluting coronary stent system. The Company plans to launch the product in the United States immediately, and it has ample inventory in all sizes. The Company launched the TAXUS system in Europe and other international markets in February of 2003 and is the leader in those markets today. "This approval is a breakthrough event for the treatment of cardiovascular disease in the United States," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "Broad, consistent clinical data and extensive real-world experience have clearly demonstrated that polymer-based delivery of paclitaxel is a safe and effective therapy that dramatically reduces restenosis. These attributes are complemented by the outstanding deliverability of the TAXUS stent system. Today's approval of the TAXUS system makes this revolutionary new therapy commercially available for the first time in the United States. We are pleased to provide U.S. physicians with this innovative technology, which will help so many patients live better lives." "We are maintaining the financial goals we outlined at last week's analyst meeting," Tobin added. "Events that have occurred subsequent to the meeting have not altered our goals." "The approval of the TAXUS system marks an important opportunity for clinicians in the United States," said Gregg Stone, M.D., Vice Chairman of the Cardiovascular Research Foundation at the Lenox Hill Heart and Vascular Institute in New York, and Principal Investigator of the TAXUS IV clinical trial. "In paclitaxel, we now have a multi- functional drug that is safe and highly effective. The TAXUS system has shown impressive results across a wide range of patients. Its performance has been particularly impressive in challenging cases such as patients with diabetes, small vessels and long lesions." "The TAXUS system is a welcome new ally in the fight against cardiovascular disease," said Stephen Ellis, M.D., Director of the Sones Cardiac Catheterization Laboratories at the Cleveland Clinic, and the Co-Principal Investigator of the TAXUS IV trial. "It offers a well-regarded drug in combination with a delivery system that is exceptionally flexible and conformable." The TAXUS product will use the Express(2)(TM) coronary stent on the Maverick(TM) balloon catheter as its platform. Together, they form the Express(2)(TM) coronary stent system, which is known for its excellent deliverability and conformability. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com. This press release contains forward-looking statements. The Company wishes to caution the reader that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with clinical trials, the regulatory approval process, physician acceptance of new products, litigation, competitive product offerings and other factors described in the Company's filings with the Securities and Exchange Commission. CONTACT: Milan Kofol 508-650-8569 (Office) 617-834-8595 (Mobile) Investor Relations Boston Scientific Corporation Paul Donovan 508-650-8541 (Office) 508-667-5165 (Mobile) Media Relations Boston Scientific Corporation -----END PRIVACY-ENHANCED MESSAGE-----