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ev3 Announces Enrollment Has Begun for SpideRX(TM) Embolic
Protection Device in Second Phase of Carotid Clinical Trial
PLYMOUTH, Minn., March 21 /PRNewswire/ -- ev3 Inc., a privately held
endovascular medical device company, has received approval to include the
SpideRX(TM) Embolic Protection Device in the second arm of the company's
Carotid Clinical Trial. 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.
ev3 has completed enrollment in the first phase of this trial using the
SPIDER(TM) Embolic Device and the Protege(R) GPS(TM) Self-Expanding Stent. The
30-day results of the first phase will be presented in a late- breaking trials
session at the Society of Interventional Radiologists meeting on April 3, in
New Orleans. The second phase of the trial will evaluate the SpideRX Device
when used with the approved and commercially available GUIDANT RX ACCULINK(TM)
Carotid Stent System. The trial is called CREATE (carotid revascularization
with ev3 arterial technology evolution).
"We believe this trial will provide our investigators with the opportunity to
gain important clinical experience with our rapid exchange embolic protection
system and the already available GUIDANT RX ACCULINK Carotid Stent System,"
stated Ginny Kirby, vice president of clinical affairs at ev3. "This will
demonstrate the SpideRX Device compatibility with both the Protege and the
GUIDANT RX ACCULINK Carotid Stent System."
The SpideRX Device, like its predecessor product, has a unique nitinol filter.
(Nitinol is an alloy commonly used in interventional products.) The new 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.
Dr. Robert Safian, William Beaumont Hospital, Royal Oak, Mich., and Dr. Gary
Ansel, Riverside Hospital, Columbus, Ohio, are national Co-Principal
Investigators for the CREATE Trial. Dr. Safian stated, "The SPIDER Embolic
Protection Device, which we studied in the CREATE Trial, is a unique distal
embolic protection device that has several advantages over other protection
devices, especially with regard to its ease of use and reliable delivery. The
SpideRX Device is even easier to use by allowing the operator to use a rapid
exchange delivery system."
The SpideRX Device is currently commercially available in Europe and several
countries in Latin America and Asia.
Carotid arteries, located on either side of the neck, are the main conduits for
blood flow to the brain. When narrowing occurs, patients are at risk for
stroke. According to the American Heart Association, more than 700,000
Americans have strokes each year, with an estimated 164,000 resulting in death.
About ev3
ev3 Inc., privately held and based in Plymouth, Minnesota, was founded in 2000.
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) and SpideRX(TM) Embolic Protection devices are
investigational devices limited by federal (U.S.) law to investigational use in
the United States. The SPIDER and SpideRX(TM) and Devices are not available
for sale in the United States.
SPIDER, SpideRX and ev3 are trademarks of ev3 Inc.
ACCULINK is a trademark of GUIDANT Corporation
GUIDANT is a registered trademark of GUIDANT Corporation
DATASOURCE: ev3 Inc.
CONTACT: Tom Timbie, CFO of ev3 Inc., +1-763-398-7000, ;
or, Marian Briggs, +1-612-455-1742, , Laura Spitzack,
+1-612-455-1782, , both of Padilla Speer Beardsley
Web site: http://www.ev3.net/