SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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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):
September 29, 1998
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THERMO CARDIOSYSTEMS INC.
(Exact name of Registrant as specified in its charter)
Massachusetts 1-10114 04-3027040
(State or other (Commission (I.R.S. Employer
jurisdiction of File Number) Identification Number)
incorporation or
organization)
470 Wildwood Street
Woburn, Massachusetts 01888
Address of principal executive offices) (Zip Code)
(781) 932-8668
(Registrant's telephone number
including area code)
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This Form 8-K contains forward-looking statements that involve a number of
risks and uncertainties. Important factors that could cause actual results to
differ materially from those indicated by such forward-looking statements are
set forth under the heading "Forward-looking Statements" in Exhibit 13 to Thermo
Cardiosystems Inc.'s Annual Report on Form 10-K for the year ended January 3,
1998. These include risks and uncertainties relating to: regulatory approvals,
reimbursement by insurers, medical community acceptance, technological change
and competition, intellectual property rights, availability of materials and
components, limited experience in commercializing LVAS products, product
liability, international operations and sales, and the potential impact of the
year 2000 on processing date-sensitive information.
Item 5. Other Events
On September 29, 1998, Thermo Cardiosystems Inc. ("Thermo Cardiosystems")
issued a press release announcing that the U.S. Food and Drug Administration
("FDA") has approved Thermo Cardiosystems' electric HeartMate(R) left
ventricular-assist system ("LVAS") for commercial sale as a bridge to heart
transplant. The electric HeartMate LVAS is an implantable heart-assist system
designed to allow heart-transplant candidates to return home while waiting for a
donor heart.
In addition, on September 29, 1998, Baxter Healthcare Corporation, the
principal U.S. operating subsidiary of Baxter International Inc., announced that
it has received pre-market approval from the FDA for its Novacor(R) Left
Ventricular Assist System in the United States as a bridge to heart transplant.
Item 7. Financial Statements, Pro Forma Financial Information and Exhibits
(a) Financial Statements of Business Acquired: not
applicable.
(b) Pro Forma Financial Information: not applicable.
(c) Exhibits: not applicable.
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized, on this 30th day of September, 1998.
THERMO CARDIOSYSTEMS INC.
By:/s/ Kenneth J. Apicerno
Kenneth J. Apicerno
Treasurer
