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Micro Therapeutics Receives Favorable FDA Audit Results (PR Newswire)...the FDA granted MTI approval to begin a pivotal clinical trial of the company`s Onyx(TM) Liquid Embolic System (Onyx LES(TM)) to study the treatment of brain aneurysms.......MTI has already received CE Mark approval to commercialize Onyx for the treatment of aneurysms, AVMs, brain tumors and peripheral vascular conditions....- May 02 12:00 PM ET


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Posted on: 05/02/2001

"Yahoo - Micro Therapeutics Receives Favorable FDA Audit Results"
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Wednesday May 2, 12:00 pm Eastern Time

Press Release

SOURCE: Micro Therapeutics, Inc.

Micro Therapeutics Receives Favorable FDA Audit Results

IRVINE, Calif., May 2 /PRNewswire/ -- Micro Therapeutics, Inc. (Nasdaq: MTIX - news) today announced that the Food and Drug Administration (FDA) has completed its periodic audit of the company's manufacturing facility and quality system, and that no violations from FDA Quality System / Good Manufacturing Practices were observed.

"This positive outcome is a reflection of the hard work of all our employees," said John Rush, president and chief executive officer of the Irvine, California-based medical device company. "We are mindful everyday that our patients and doctors rely on the high quality of our devices."

The FDA audit is mandated by Congress in Section 704 A of the Federal Food, Drug and Cosmetic Act. By law, the FDA is to conduct onsite investigations of medical device manufacturers every two years to analyze the facility's quality systems and processes. The audit assesses the manufacturing environment, employee training, device sterilization, management involvement, organization of the company and response to customer complaints.

This announcement comes on the heels of several important achievements for MTI. In late March, the FDA granted MTI approval to begin a pivotal clinical trial of the company's Onyx(TM) Liquid Embolic System (Onyx LES(TM)) to study the treatment of brain aneurysms. And just two weeks after that, the company received FDA approval to begin a similar clinical trial for the treatment of arteriovenous malformations (AVMs). Onyx is a liquid embolic material that is delivered through MTI's proprietary micro catheters directly into a targeted vascular malformation, such as an aneurysm or AVM. Once inside the targeted malformation, the liquid quickly transforms into a spongy polymer mass designed to seal off the malformation from blood flow, thus precluding a rupture and subsequent stroke.

In Europe, MTI has already received CE Mark approval to commercialize Onyx for the treatment of aneurysms, AVMs, brain tumors and peripheral vascular conditions. Investigational studies in Japan are planned but have not yet commenced. Worldwide, across all therapies, the company estimates that Onyx has been used in more than 800 procedures.

About Micro Therapeutics

Micro Therapeutics, Inc. (MTI) develops, manufactures and markets minimally invasive devices for the treatment of neuro and peripheral vascular disease. MTI entered the medical device industry in June 1993 and shortly thereafter launched a single line of minimally invasive devices for the treatment of blood clots. Today, MTI's product line portfolio includes more than 130 medical devices serving the neuro vascular and peripheral vascular markets.

Statements contained in this press release which are not historical information are forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks and uncertainties which could cause actual results to differ materially from those projected or implied. Such potential risks and uncertainties relate, but are not limited, to, in no particular order: effectiveness and pace of current and future product development, success of clinical testing, product demand and market acceptance, the impact of competitive products and pricing, and regulatory approval. More detailed information on these and additional factors which could affect Micro Therapeutics, Inc.'s operating and financial results are described in the company's Forms 10-QSB, 10-KSB and other reports, filed or to be filed with the Securities and Exchange Commission. Micro Therapeutics, Inc. urges all interested parties to read these reports to gain a better understanding of the many business and other risks that the company faces. Additionally, Micro Therapeutics, Inc. undertakes no obligation to publicly release the results of any revisions to these forward-looking statements, which may be made to reflect events or circumstances occurring after the date hereof or to reflect the occurrence of unanticipated events.

For further information please contact: media, Brennan Pope, ext. 161, bpope@fischerhealth.com, or Megan Taylor, ext. 165, mtaylor@fischerhealth.com, both of Fischer & Partners, Inc., 310-577-7870, for Micro Therapeutics, Inc.; or investors, Harold A. Hurwitz of Micro Therapeutics, Inc., 949-837-3700.

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SOURCE: Micro Therapeutics, Inc.

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