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ev3 Receives Investigational Device Exemption for Use of
SpideRX(TM) Embolic Protection Device in Clinical Trial
PLYMOUTH, Minn., Dec. 6 /PRNewswire/ -- ev3(R) Inc., a privately held
endovascular medical device company, has received an investigational device
exemption (IDE) approval from the U.S. Food and Drug Administration for the
company's SpideRX(TM) Embolic Protection Device for inclusion in the ongoing
SPIDER Saphenous Vein Graft Clinical Trial. The company plans to introduce the
next-generation rapid exchange SpideRX Device into the trial immediately.
Embolic protection devices are small filters placed within a blood vessel to
capture and remove plaque particles dislodged during interventional procedures,
such as angioplasty or stenting, to prevent stroke or heart attack.
"This is a significant addition to our ongoing trial," stated Ginny Kirby, ev3
vice president of clinical affairs. "We believe including the SpideRX Device
will provide our investigators with the opportunity to gain important clinical
experience with leading edge technology as they work with us to demonstrate the
overall safety and effectiveness of our embolic protection system."
The new SpideRX Device is designed to provide more efficient delivery, capture
and recovery while still allowing interventionalists to use their
interventional wire of choice. Improvements over the current device include a
complete rapid exchange system, 6 Fr. guide catheter compatibility and a unique
dual-end delivery/recovery catheter with a pre-loaded capture wire. Like its
predecessor product, the SpideRX Device has a unique nitinol filter. (Nitinol
is an alloy commonly used in interventional products.)
Dr. William O'Neill, principal investigator for the SPIDER Trial of William
Beaumont Hospital, added, "The SpideRX Device, without question, will become
the dominant distal protection device once it is cleared. It provides all the
advantages of the SPIDER(TM) Device, including the ability to use standard
wires to access the distal vessel, as well as the flexibility of the distal
filter. In addition, the RX design will dramatically simplify the procedure
and decrease procedure time. The operators will be able to perform distal
protection with a single operator approach that fits easily into the modern
cath. lab environment."
The purpose of the trial is to establish the safety and efficacy of this
embolic protection device in patients who have a significant narrowing of a
saphenous vein graft. This clinical trial includes 80 centers and will enroll
over 1,000 patients.
ev3 received CE Mark approval for the SpideRX Device in June 2004. The product
is commercially available in Europe and several countries in Latin America and
Asia.
About ev3
ev3 Inc., privately held and based in Plymouth, Minn., was founded in 2001.
ev3 Inc. is a global medical device company that is focused on innovative
endovascular technologies for the minimally invasive treatment of coronary,
neurovascular, and peripheral vascular diseases and disorders. In 2001, ev3
established a strategic relationship with Micro Therapeutics, Inc.
(NASDAQ:MTIX), a leader in the market for catheter-based neurovascular devices.
ev3 Inc. and Micro Therapeutics, Inc. are majority owned by ev3 LLC, a private
equity partnership organized by Warburg Pincus and the Vertical Group, two of
the most successful institutional investors in the medical device industry.
More information about ev3 and its products can be found at http://www.ev3.net/
.
** The SPIDER(TM) Embolic Protection device is an investigational device
limited by federal (U.S.) law to investigational use in the United States. For
carotid use, the Protege(R) GPS(TM) Stent is limited by federal (U.S.) law as
"investigational only" in the United States. The SpideRX(TM) and Protege(R)
GPS(TM) Tapered Devices are not available in the United States.
ev3, Protege, Protege GPS, SPIDER, SpideRX, X-SIZER, PLAATO, IntraCoil,
ParaMount, IntraStent, AqWire, Nitrex and Goose Neck are trademarks of ev3(R)
Inc.
Micro Therapeutics, Sapphire, Onyx, and Echelon are trademarks of Micro
Therapeutics, Inc.
DATASOURCE: ev3 Inc.
CONTACT: Cheryl Newell, CFO of ev3, Inc., +1-763-398-7000,
; or Nancy A. Johnson, +1-612-455-1745, ,
or Marian Briggs, +1-612-455-1742, , both of Padilla Speer
Beardsley for ev3 Inc.
Web site: http://www.ev3.net/