Micro Therapeutics Receives FDA Approval for Pivotal Trial of Onyx For Arteriovenous Malformations

Second Major FDA Approval for Company in Two Weeks



Apr 11, 2001, 01:00 ET from Micro Therapeutics, Inc.

    IRVINE, Calif., April 11 /PRNewswire/ -- Micro Therapeutics, Inc.
 (Nasdaq: MTIX) today announced it obtained FDA approval to begin a 106-patient
 pivotal trial of the company's Onyx(TM) Liquid Embolic System (Onyx LES(TM))
 for the treatment of arteriovenous malformations (AVMs) at 15 sites in the
 U.S.  The announcement comes only two weeks after the FDA approved MTI's
 pivotal trial of Onyx for aneurysms.
     "In this short time span, we received two vital approvals from the FDA,"
 said John Rush, president and chief executive officer of the Irvine,
 California-based medical device company.  "First came the approval in late
 March to commence pivotal trials for the use of Onyx in treating brain
 aneurysms, and now the FDA has approved the beginning of the AVM trial.  We
 have already started the process of enlisting clinical study sites across the
 U.S., and we expect to commence patient enrollment this quarter."
     The AVM trial will 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.
     "Onyx is non-adhesive, which we believe is a major advantage over glue,
 the other embolic agent used in AVM treatments," continued Rush.  "This allows
 the physician to inject Onyx at a controlled rate, and affords time for
 thoughtful decision-making during the treatment."
     Among the sites performing cases under the trial, subject to completion of
 their individual Institutional Review Board approval processes, are: UCLA,
 under the leadership of Gary Duckwiler, M.D., who will be the principal
 investigator for the study; Methodist Hospital in Houston, Texas; State
 University of New York in Buffalo, NY; and Beth Israel Medical Center in New
 York City.
     "The FDA approval of the pivotal trial, while requiring MTI to provide
 certain remaining information to the FDA, gives MTI the go-ahead to commence
 the trial at all 15 sites and for the full complement of cases.  MTI
 anticipates full enrollment of the 106 patients to take approximately one
 year.  Upon completion of the pivotal trial, MTI expects to file a Pre-Market
 Approval application with the FDA for its clearance to market Onyx for the
 treatment of AVMs in the U.S.
     MTI's program for the use of Onyx in treating AVMs began with feasibility
 studies in December 1996, and continued through 1999 with studies under an
 Investigational Device Exemption sponsored by UCLA.
     Similarly, clinical studies in Europe were initiated by MTI in 1998, which
 culminated in the receipt of CE Mark approval to market Onyx for the treatment
 of AVMs in July 1999.  "We are pleased with the ramp-up of Onyx for use in AVM
 treatments in Europe, where Onyx already has achieved market share leadership
 in the U.K. and Spain," commented Rush.  "Working with Guidant Corporation,
 our exclusive European distribution partner, we look forward to expanding this
 leadership role."
     AVMs are a cluster of abnormally formed blood vessels that directly
 connect arteries and veins.  When the weaker venous walls of an AVM are
 challenged by the higher pressure of arterial blood flow, the veins can
 rupture, causing life-threatening bleeding in the brain.  To date, Onyx has
 been used in an estimated 650 AVM procedures worldwide.
 
     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 AVM or aneurysm.  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.  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.
     Onyx also has marketing approval in Europe for use in the treatment of
 brain aneurysms.  Physicians in Europe are currently performing cases under
 MTI's 100-patient CAMEO Registry, which the company expects to be completed in
 May 2001.  At that point, Onyx for aneurysm treatments will be commercially
 launched in Europe through Guidant.
     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,
 310-577-7870 ext. 161, bpope@fischerhealth.com, or Megan Taylor, 310-577-7870
 ext. 165, mtaylor@fischerhealth.com, both of Fischer & Partners, Inc., for
 Micro Therapeutics, Inc.; or Investors, Harold A. Hurwitz of Micro
 Therapeutics, Inc., 949-837-3700 ext. 230, hal.hurwitz@microtherapeutics.com
 
 

SOURCE Micro Therapeutics, Inc.
    IRVINE, Calif., April 11 /PRNewswire/ -- Micro Therapeutics, Inc.
 (Nasdaq: MTIX) today announced it obtained FDA approval to begin a 106-patient
 pivotal trial of the company's Onyx(TM) Liquid Embolic System (Onyx LES(TM))
 for the treatment of arteriovenous malformations (AVMs) at 15 sites in the
 U.S.  The announcement comes only two weeks after the FDA approved MTI's
 pivotal trial of Onyx for aneurysms.
     "In this short time span, we received two vital approvals from the FDA,"
 said John Rush, president and chief executive officer of the Irvine,
 California-based medical device company.  "First came the approval in late
 March to commence pivotal trials for the use of Onyx in treating brain
 aneurysms, and now the FDA has approved the beginning of the AVM trial.  We
 have already started the process of enlisting clinical study sites across the
 U.S., and we expect to commence patient enrollment this quarter."
     The AVM trial will 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.
     "Onyx is non-adhesive, which we believe is a major advantage over glue,
 the other embolic agent used in AVM treatments," continued Rush.  "This allows
 the physician to inject Onyx at a controlled rate, and affords time for
 thoughtful decision-making during the treatment."
     Among the sites performing cases under the trial, subject to completion of
 their individual Institutional Review Board approval processes, are: UCLA,
 under the leadership of Gary Duckwiler, M.D., who will be the principal
 investigator for the study; Methodist Hospital in Houston, Texas; State
 University of New York in Buffalo, NY; and Beth Israel Medical Center in New
 York City.
     "The FDA approval of the pivotal trial, while requiring MTI to provide
 certain remaining information to the FDA, gives MTI the go-ahead to commence
 the trial at all 15 sites and for the full complement of cases.  MTI
 anticipates full enrollment of the 106 patients to take approximately one
 year.  Upon completion of the pivotal trial, MTI expects to file a Pre-Market
 Approval application with the FDA for its clearance to market Onyx for the
 treatment of AVMs in the U.S.
     MTI's program for the use of Onyx in treating AVMs began with feasibility
 studies in December 1996, and continued through 1999 with studies under an
 Investigational Device Exemption sponsored by UCLA.
     Similarly, clinical studies in Europe were initiated by MTI in 1998, which
 culminated in the receipt of CE Mark approval to market Onyx for the treatment
 of AVMs in July 1999.  "We are pleased with the ramp-up of Onyx for use in AVM
 treatments in Europe, where Onyx already has achieved market share leadership
 in the U.K. and Spain," commented Rush.  "Working with Guidant Corporation,
 our exclusive European distribution partner, we look forward to expanding this
 leadership role."
     AVMs are a cluster of abnormally formed blood vessels that directly
 connect arteries and veins.  When the weaker venous walls of an AVM are
 challenged by the higher pressure of arterial blood flow, the veins can
 rupture, causing life-threatening bleeding in the brain.  To date, Onyx has
 been used in an estimated 650 AVM procedures worldwide.
 
     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 AVM or aneurysm.  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.  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.
     Onyx also has marketing approval in Europe for use in the treatment of
 brain aneurysms.  Physicians in Europe are currently performing cases under
 MTI's 100-patient CAMEO Registry, which the company expects to be completed in
 May 2001.  At that point, Onyx for aneurysm treatments will be commercially
 launched in Europe through Guidant.
     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,
 310-577-7870 ext. 161, bpope@fischerhealth.com, or Megan Taylor, 310-577-7870
 ext. 165, mtaylor@fischerhealth.com, both of Fischer & Partners, Inc., for
 Micro Therapeutics, Inc.; or Investors, Harold A. Hurwitz of Micro
 Therapeutics, Inc., 949-837-3700 ext. 230, hal.hurwitz@microtherapeutics.com
 
 SOURCE  Micro Therapeutics, Inc.