FORM 8-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest
event reported): October 31, 1995
ANGEION CORPORATION
(Exact name of registrant as specified in its charter)
Minnesota 0-17019 41-1579150
(State of incorporation) (Commission (I.R.S. Employer
File Number) Identification No.)
3650 Annapolis Lane, Suite 170, Plymouth, Minnesota 55447
(Address of principal executive offices) (zip code)
Registrant's telephone number, including area code: 612/550-9388
Item 5. Other Events
Filed herewith and incorporated herein by reference is a press release
dated October 31, 1995 reporting that Angeion Corporation (the "Company")
received an investigational device exemption from the United States Food and
Drug Administration on its Sentinel(TM) 2000 implantable cardioverter
defibrillator system. The press release also reports that the Company's Vice
President of Research and Product Planning has joined the Company's strategic
partner.
Item 7. Financial Statements, Pro Forma Financial Information and Exhibits.
c. Exhibits
99.1 Press Release, dated October 31, 1995
SIGNATURES
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 hereunto duly authorized.
ANGEION CORPORATION
/s/David L. Christofferson
David L. Christofferson
Chief Financial Officer
Dated: November 1, 1995
INDEX TO EXHIBITS
Exhibit No. Item Method of Filing
99.1 Press Release, dated October 31, 1995 Filed herewith
FOR IMMEDIATE RELEASE Contact: David Christofferson
Angeion Corporation
612/550-9388
Angeion Receives FDA Authorization
to Conduct Clinical Trials
Minneapolis (October 31, 1995) -- Angeion Corporation (Nasdaq: ANGN) announced
today that it has received an investigational device exemption (IDE) from the
United States Food and Drug Administration (FDA) on its Sentinel (TM) 2000
implantable cardioverter defibrillator system. The IDE allows Angeion to conduct
clinical trials of the Sentinel system in the United States and to perform up to
60 implants in up to 15 centers nationwide.
"We are extremely pleased by the FDA's rapid response to our IDE
application to conduct clinical trials in the United States," said Whitney A.
McFarlin, Angeion Chairman, President and CEO. "Our team did an excellent job in
preparing this high quality submission. We look forward to building our U.S.
clinical program, compiling performance data and most importantly offering
physicians and their patients the advantages of the smallest full function
defibrillator."
Earlier this year, Angeion initiated clinical trials of the Sentinel 2000
in Europe. Implants began in Germany, followed by Italy and most recently in the
United Kingdom. Angeion has applied for Conformite Europeene (CE) Mark approval.
The CE Mark will allow Angeion to market the Sentinel system throughout Europe.
The Sentinel system is designed to improve monitoring and therapy while
increasing patient comfort, reducing costs, easing implantation procedures, and
reducing patient trauma and recovery time.
ICDs are permanently implanted to provide electrical therapy for patients
suffering from life-threatening rapid irregular heartbeats originating in the
ventricles, or lower chambers of the heart.
In a separate matter, Angeion announced that Mark Kroll, Ph.D., vice
president of research and product planning at Angeion has joined Angeion's
strategic partner Pacesetter, Inc., a St. Jude Medical company. Kroll will serve
as Angeion's primary contact at California-based Pacesetter and direct the
cooperative effort established between the two companies in 1993. Recently
Angeion began to provide Sentinel systems to Pacesetter for its preclinical
trials of Angeion's ICD system.
Minneapolis-based Angeion Corporation develops and markets devices to treat
life-threatening rapid irregular heartbeats.
END
