-----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, QS/IlxZQyI/mm7dG46CB4VIdsZPndxWA4rXFHyuDzDe7GSpmW4DlUCMT3iHjtEU2 TCjOzsZ9DZS7yHv25OPFKg== 0001072613-10-000578.txt : 20100521 0001072613-10-000578.hdr.sgml : 20100521 20100520192730 ACCESSION NUMBER: 0001072613-10-000578 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20100520 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100521 DATE AS OF CHANGE: 20100520 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: 10849152 BUSINESS ADDRESS: STREET 1: ONE BOSTON SCIENTIFIC PL CITY: NATICK STATE: MA ZIP: 01760-1537 BUSINESS PHONE: 5086508000 8-K 1 form8-k_16833.htm BOSTON SCIENTIFIC CORP. FORM 8-K form8-k_16833.htm


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): May 20, 2010

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

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨
Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
¨
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
¨
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
¨
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 



 
 
 
 

ITEM 8.01. 
OTHER EVENTS.

As a follow-up to the actions described in Boston Scientific’s press releases of March 15 and April 15, 2010, the Company has received U.S. Food and Drug Administration clearance for manufacturing changes to its LIVIAN™ and RENEWAL® cardiac resynchronization therapy defibrillators (CRT-Ds) and CONFIENT™, PRIZM™ and VITALITY™ implantable cardioverter defibrillators (ICDs) and is immediately resuming U.S. distribution of these products.   The Company has now resumed U.S. distribution of all its CRT-D and ICD devices.


ITEM 9.01.                      FINANCIAL STATEMENTS AND EXHIBITS.

Exhibit No
Description

Exhibit 99.1: 
Letter to Physicians.
Exhibit 99.2: 
Letter to Patients.

 
 
 
 
- 2 -

 
 
 
SIGNATURE


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:   May 20, 2010
By:
/s/ Timothy A. Pratt  
    Timothy A. Pratt  
   
Executive Vice President, Chief Administrative Officer, General Counsel and Secretary
 
       


 
 
 

 
 
- 3 -

 

INDEX TO EXHIBITS

 

Exhibit No
Description

Exhibit 99.1: 
Letter to Physicians.
Exhibit 99.2: 
Letter to Patients.
 
 
 
 

 
 
 
 
- 4 -

 

 
 
 
 
 
EX-99.1 2 exhibit99-1_16833.htm PHYSICIAN LETTER exhibit99-1_16833.htm
Exhibit 99.1

LOGO
 
4100 Hamline Avenue North
St. Paul, MN 55112-5798
www.bostonscientific.com

May 2010


Subject: U.S. distribution of all Boston Scientific CRT-D and ICD devices has resumed


Dear Doctor:

We are writing to inform you that we have received U.S. Food and Drug Administration clearance for manufacturing changes to our LIVIAN™ and RENEWAL® cardiac resynchronization therapy defibrillators (CRT-Ds) and CONFIENT™, PRIZM™ and VITALITY™ implantable cardioverter defibrillators (ICDs), and we have resumed U.S. distribution of these products.  We have now resumed U.S. distribution of all our CRT-Ds and ICDs, and you may implant all these devices.  Your local sales representative will work with your hospital to replenish inventory.

Throughout this process there has been no indication of any risk to patient safety.  We do not recommend any modifications to normal follow-up procedure for patients previously implanted with Boston Scientific CRT-Ds or ICDs.

We are pleased we are again able to provide you and your patients the benefits of our defibrillation products.  We would like to thank you for your patience and support as we worked through this situation.

If you have questions, please contact your local Boston Scientific sales representative or U.S. Technical Services at 1.800.CARDIAC (227.3422).

Sincerely,

 
Hank Kucheman
Group President; Cardiology, Rhythm & Vascular
Boston Scientific Corporation
Kenneth Stein, M.D.
Chief Medical Officer
Boston Scientific CRM
 
EX-99.2 3 exhibit99-2_16833.htm PATIENT LETTER exhibit99-2_16833.htm
Exhibit 99.2

LOGO
 
4100 Hamline Avenue North
St. Paul, MN 55112-5798
www.bostonscientific.com



May 2010


Dear Patient:

We want you to know that we have resumed distribution of all of our cardiac resynchronization therapy defibrillators (CRT-Ds) and implantable cardioverter defibrillators (ICDs) to hospitals in the United States.  Throughout this process there has been no indication of any risk to patient safety, so there is nothing you or your heart doctor need to do differently for your implanted device.
 
We encourage you to contact your heart doctor or Boston Scientific Patient Services if you have questions.  You can reach our Patient Services team by calling 1.866.484.3268 and pressing “2” when prompted.

Sincerely,


 
Hank Kucheman
Group President; Cardiology, Rhythm & Vascular
Boston Scientific Corporation
Kenneth Stein, M.D.
Chief Medical Officer
Boston Scientific CRM
 
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