First Case Completed in Micro Therapeutics' Aneurysm Pivotal Trial; Patient Enrollment Commences Just Two Weeks After FDA Approves Study

Apr 18, 2001, 01:00 ET from Micro Therapeutics, Inc.

    IRVINE, Calif., April 18 /PRNewswire/ -- Micro Therapeutics, Inc.
 (Nasdaq:   MTIX) announced today that the first patient has been treated under
 its FDA-approved aneurysm pivotal trial using the company's Onyx(TM) Liquid
 Embolic System (Onyx LES(TM)), only two weeks after the FDA granted approval
 to MTI to begin this study.
     The procedure was performed by Dr. Andrew Gyorke at Tucson Medical Center
 on a 60 year-old patient suffering from a giant aneurysm, defined as having at
 least one dimension exceeding 25 mm.
     "We were able to fill greater than 99% of the aneurysm sac with Onyx,"
 said Dr. Gyorke, M.D.  "The patient has been released from the hospital and
 appears to be neurologically intact."
     "It is our pleasure to welcome Dr. Gyorke into the study," said John Rush,
 president and chief executive officer of the Irvine, California-based medical
 device company.  "We believe the completion of this case is evidence of our
 quickened pace, and our early success in expanding the study to include new
 institutions."
     In late March, MTI received FDA approval to begin this study, which will
 encompass 138 patients at 15 sites.  The pivotal trial marks the first
 randomized, direct comparison of Onyx to detachable coils, the only other
 existing interventional treatment for aneurysms.  The study isled by Dr.
 Michel Mawad, chief of interventional neuroradiology at Methodist Hospital in
 Houston, Texas and consists of two, equal-sized patient groups -- one group to
 be treated with Onyx and the other group to be treated with detachable coils.
 MTI expects full enrollment of patients to take approximately one year, with
 an additional six months needed for the accumulation of required case
 follow-up data.  MTI anticipates filing a Pre-Market Approval application with
 the FDA in the second half of 2002 and expects FDA review of the application
 to take approximately one year.
     Among the hospitals joining Tucson Medical Center in the pivotal trial,
 subject to completion of their individual Institutional Review Board approval
 processes, are Methodist Hospital; State University of New York in Buffalo,
 NY; and Beth Israel Medical Center in New York City.
     In Europe, where MTI has already received CE Mark approval to
 commercialize Onyx for the treatment of aneurysms, 72 cases have been
 performed under the company's 100-patient CAMEO (Cerebral Aneurysm
 Multi-Center European Onyx) Registry.  MTI expects to complete the CAMEO
 Registry in the second quarter of 2001, after which the Onyx aneurysm therapy
 will be commercially launched through Guidant Corporation, MTI's European
 distribution partner.
     To date, Onyx has been used worldwide in 88 brain aneurysm cases,
 encompassing 92 procedures, with completely successful acute results, measured
 as having the ability to fill at least 90 percent of the aneurysm sac with
 Onyx.  Three-month follow-up has been performed in 37 cases, and six-month
 follow-up has been performed on 10 cases, with only four aneurysms having
 required re-treatment, a statistic that has remained stable for over nine
 months.
     In addition to the aneurysm pivotal trials, MTI has also begun an
 FDA-approved pivotal trial of Onyx for the treatment of arteriovenous
 malformations (AVMs).  AVMs are a "bird's nest" cluster of abnormally formed
 blood vessels that directly connect arteries and veins.  When the higher
 pressure of arterial blood flow challenges the weaker venous walls of an AVM,
 the veins can rupture, causing life-threatening bleeding in the brain and
 stroke.  The AVM trial will also consist of two equal "arms" of patient
 groups, one whose AVMs will be treated with Onyx, and the other with a
 cyanocrylate glue which received clearance from the FDA in late 2000.  As
 opposed to glue, Onyx is non-adhesive.  This is expected to be a major
 advantage, in that it allows the physician to inject Onyx at a controlled
 rate, and affords time for thoughtful decision-making during the treatment.
 
     About Onyx
     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.  Onyx is non-adhesive, which enhances
 controllability during delivery, and it is visible under fluoroscopy --
 allowing clinicians a clear view of the embolization procedure in real-time.
     In Europe, MTI has received CE Mark to commercially promote Onyx for use
 in the treatment of aneurysms, AVMs and certain peripheral applications.
 Investigational studies in Japan are planned but have not yet commenced.
 Worldwide, across all therapies, Onyx has been used in approximately
 800 procedures.
 
     About Micro Therapeutics, Inc.
     Micro Therapeutics develops, manufactures and markets minimally invasive
 devices for the diagnosis and treatment of vascular disease.  MTI was founded
 in June 1993 and shortly thereafter, launched a single line of minimally
 invasive devices for the treatment of blood clots.  In addition to Onyx LES,
 MTI's current 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 include, but are not limited to, in no particular order:
 product development, risks and results of clinical testing, demand and market
 acceptance risks, the impact of competitive products and pricing, regulatory
 approval and future product development.  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 prospectus dated
 February 18, 1997, as well as in its 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.
 
 

SOURCE Micro Therapeutics, Inc.
    IRVINE, Calif., April 18 /PRNewswire/ -- Micro Therapeutics, Inc.
 (Nasdaq:   MTIX) announced today that the first patient has been treated under
 its FDA-approved aneurysm pivotal trial using the company's Onyx(TM) Liquid
 Embolic System (Onyx LES(TM)), only two weeks after the FDA granted approval
 to MTI to begin this study.
     The procedure was performed by Dr. Andrew Gyorke at Tucson Medical Center
 on a 60 year-old patient suffering from a giant aneurysm, defined as having at
 least one dimension exceeding 25 mm.
     "We were able to fill greater than 99% of the aneurysm sac with Onyx,"
 said Dr. Gyorke, M.D.  "The patient has been released from the hospital and
 appears to be neurologically intact."
     "It is our pleasure to welcome Dr. Gyorke into the study," said John Rush,
 president and chief executive officer of the Irvine, California-based medical
 device company.  "We believe the completion of this case is evidence of our
 quickened pace, and our early success in expanding the study to include new
 institutions."
     In late March, MTI received FDA approval to begin this study, which will
 encompass 138 patients at 15 sites.  The pivotal trial marks the first
 randomized, direct comparison of Onyx to detachable coils, the only other
 existing interventional treatment for aneurysms.  The study isled by Dr.
 Michel Mawad, chief of interventional neuroradiology at Methodist Hospital in
 Houston, Texas and consists of two, equal-sized patient groups -- one group to
 be treated with Onyx and the other group to be treated with detachable coils.
 MTI expects full enrollment of patients to take approximately one year, with
 an additional six months needed for the accumulation of required case
 follow-up data.  MTI anticipates filing a Pre-Market Approval application with
 the FDA in the second half of 2002 and expects FDA review of the application
 to take approximately one year.
     Among the hospitals joining Tucson Medical Center in the pivotal trial,
 subject to completion of their individual Institutional Review Board approval
 processes, are Methodist Hospital; State University of New York in Buffalo,
 NY; and Beth Israel Medical Center in New York City.
     In Europe, where MTI has already received CE Mark approval to
 commercialize Onyx for the treatment of aneurysms, 72 cases have been
 performed under the company's 100-patient CAMEO (Cerebral Aneurysm
 Multi-Center European Onyx) Registry.  MTI expects to complete the CAMEO
 Registry in the second quarter of 2001, after which the Onyx aneurysm therapy
 will be commercially launched through Guidant Corporation, MTI's European
 distribution partner.
     To date, Onyx has been used worldwide in 88 brain aneurysm cases,
 encompassing 92 procedures, with completely successful acute results, measured
 as having the ability to fill at least 90 percent of the aneurysm sac with
 Onyx.  Three-month follow-up has been performed in 37 cases, and six-month
 follow-up has been performed on 10 cases, with only four aneurysms having
 required re-treatment, a statistic that has remained stable for over nine
 months.
     In addition to the aneurysm pivotal trials, MTI has also begun an
 FDA-approved pivotal trial of Onyx for the treatment of arteriovenous
 malformations (AVMs).  AVMs are a "bird's nest" cluster of abnormally formed
 blood vessels that directly connect arteries and veins.  When the higher
 pressure of arterial blood flow challenges the weaker venous walls of an AVM,
 the veins can rupture, causing life-threatening bleeding in the brain and
 stroke.  The AVM trial will also consist of two equal "arms" of patient
 groups, one whose AVMs will be treated with Onyx, and the other with a
 cyanocrylate glue which received clearance from the FDA in late 2000.  As
 opposed to glue, Onyx is non-adhesive.  This is expected to be a major
 advantage, in that it allows the physician to inject Onyx at a controlled
 rate, and affords time for thoughtful decision-making during the treatment.
 
     About Onyx
     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.  Onyx is non-adhesive, which enhances
 controllability during delivery, and it is visible under fluoroscopy --
 allowing clinicians a clear view of the embolization procedure in real-time.
     In Europe, MTI has received CE Mark to commercially promote Onyx for use
 in the treatment of aneurysms, AVMs and certain peripheral applications.
 Investigational studies in Japan are planned but have not yet commenced.
 Worldwide, across all therapies, Onyx has been used in approximately
 800 procedures.
 
     About Micro Therapeutics, Inc.
     Micro Therapeutics develops, manufactures and markets minimally invasive
 devices for the diagnosis and treatment of vascular disease.  MTI was founded
 in June 1993 and shortly thereafter, launched a single line of minimally
 invasive devices for the treatment of blood clots.  In addition to Onyx LES,
 MTI's current 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 include, but are not limited to, in no particular order:
 product development, risks and results of clinical testing, demand and market
 acceptance risks, the impact of competitive products and pricing, regulatory
 approval and future product development.  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 prospectus dated
 February 18, 1997, as well as in its 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.
 
 SOURCE  Micro Therapeutics, Inc.