UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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):
AUGUST 25,1998
ANGEION CORPORATION
(Exact name of registrant as specified in its charter)
Minnesota 0-17019 41-1579150
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(State of incorporation) (Commission (I.R.S. Employer
File Number) Identification No.)
7601 Northland Drive, Minneapolis, MN 55428-1088
(Address of principal executive offices) (zip code)
Registrant's telephone number, including area code: 612/315-2000
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Item 5. Other Events.
Filed herewith as Exhibit 99.1 and incorporated herein by reference is
a press release dated August 20, 1998 reporting that Angeion Corporation (the
"Company") has received Pre-Market Approval from the U.S. Food and Drug
Administration for its Sentinel Series of Implantable Cardioverter
Defibrillators.
Item 7. Financial Statements and Exhibits.
c. Exhibits
99.1 Press Release, dated August 20, 1998
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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/ James B. Hickey, Jr.
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James B. Hickey, Jr.
President and Chief Executive Officer
Dated: August 25, 1998
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INDEX TO EXHIBITS
Exhibit No. Item Method of Filing
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99.1 Press Release, dated August 20, 1998 Filed herewith
electronically.
EXHIBIT 99.1
ANGEION RECEIVES PRE-MARKET APPROVAL FROM FDA FOR SENTINEL(R) ICDs
COMPACT, FEATURE INTENSIVE ICDs
TO BE MARKETED TO $960 MILLION U.S. INDUSTRY
MINNEAPOLIS (August 20, 1998) -- Angeion Corporation (Nasdaq:ANGN) announced
today that it has received Pre-Market Approval (PMA) from the U.S. Food and Drug
Administration (FDA) for its Sentinel(R) Series of Implantable Cardioverter
Defibrillators (ICD). The PMA allows Angeion to market its Sentinel ICDs
throughout the United States, which represents approximately 80 percent of the
worldwide ICD market. This marks Angeion's first commercial entry into the U.S.
ICD market, which is estimated at approximately $960 million. A PMA for
Angeion's first family of ICDs should help expedite future related regulatory
approvals in the United States.
PMA approval has been granted for the Sentinel Series of four ICDs,
the Models 2000, 2010, 2011 and 2012, the AngeFlex(TM) lead system, ICD
programming system and external defibrillation test system.
Sentinel ICDs are designed to provide value to the patient and
physician by improving patient comfort, easing implantation and increasing the
long-term cost-effectiveness of ICD therapy. Angeion's ASEC(TM) (Application
Specific Electrochemistry) dual-battery system efficiently utilizes battery
chemistry and capacity to extend device longevity - offering the longest in the
industry - up to 10 years. Additional proprietary features include the Small
Cap(TM) Biphasic Waveform and programmable Hot Can(R) electrode, both designed
to lower defibrillation thresholds for increased patient safety, and sensing
configurations to expand physician choices and optimize diagnostics.
Angeion will market its ICDs in the United States through ELA*Angeion,
a joint venture it established with ELA Medical in January 1998. ELA*Angeion
employs a rapidly growing sales force which is being trained to market Angeion
and ELA Medical's arrhythmia management products to hospitals and medical
centers throughout the United States.
Whitney A. McFarlin, Angeion's Chairman said, "Receiving this PMA is a
confirmation of our commitment to the high quality and safety standards of our
Sentinel Series for the world's largest ICD market. For Angeion and its
stakeholders, the PMA is not only the capstone event in the development of our
first ICD product family, it is the commencement of the nationwide marketing
initiative to make Sentinel ICDs available to U.S. patients and doctors."
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Angeion's next development in ICD technology, the Model 2020 Series,
is currently being evaluated in U.S. clinical studies under an Investigational
Device Exemption (IDE). Upon completion of the study, a PMA supplement
application will be submitted.
Incorporating several patented features of the Sentinel Series, the
Model 2020 Series is designed to maximize diagnostic capabilities for patient
data analysis benefits by incorporating one full hour of programmable stored
electrograms and a unique, new feature called EGM Snapshot(TM), which allows the
physician to store the patient's electrogram for later retrieval and analysis.
The Model 2020 is one of the smallest ICDs to be implanted to date, with a
volume of only 46 cc and weight of 87 grams. Angeion's AngePass(TM) lead system,
which offers pacing, sensing and defibrillation capabilities in a low profile
single-pass lead system, is also in clinical studies in the United States.
Jim Hickey, Angeion's new President and CEO said, "We'll begin to make
inroads in the U.S. market with our Sentinel 2010 Series, however the Model 2020
Series, which we will submit to the FDA shortly, is where we will begin to
expect significant market impact. Our strategy has been to gain approval to
compete with the 2010 Series. We believe that the additional, more attractive
features of the 2020 Series are the keys to moving us toward profitable growth."
In June 1998, Angeion received Conformite Europeenne (CE) Mark for the
2020 Model Series. The AngePass lead system received the CE Mark in November
1997. The European standard for safety and quality assurance, the CE Mark allows
these products to be marketed in the European Union. Angeion's strategic
partner, ELA Medical, will market these products through its established
distribution network.
Angeion Corporation designs, develops and manufactures sophisticated
ICDs and catheter ablation systems for the treatment of rapid abnormal
heartbeats, the cause of death for more than 400,000 adults in the U.S. each
year. Angeion's Internet address is: http:// www.angeion.com.
The discussion above contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. These statements by their
nature involve substantial risks and uncertainties. Actual results may differ
materially depending on a variety of factors, including, but not limited to, the
following: progress with clinical trials; time and costs involved in obtaining
regulatory approvals; costs involved in filing, prosecuting and enforcing
patents and defending against patent infringement claims; competing
technological and market developments; costs of manufacturing and marketing
scale-up; funding needs of the joint venture; need to obtain additional capital;
and success of the strategic alliance with Synthelabo. Additional information
with respect to the risks and uncertainties faced by the Company may be found
in, and the prior discussion is qualified in its entirety by, the Risk Factors
contained in the Company's Current Report of Form 8-K, as filed with the SEC on
April 20, 1998, a copy of which is available upon request.
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