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ev3(TM) Receives 510(k) Marketing Clearance for X-SIZER(R)
Thrombectomy Catheter System for Dialysis Graft Use
System Mechanically Clears Blood Clots Quickly and Reliably
PLYMOUTH, Minn., Sept. 21 /PRNewswire/ -- ev3(TM) Inc., a privately held
endovascular medical device company, has received 510(k) marketing clearance
from the Food and Drug Administration (FDA) for the use of the company's
X-SIZER(R) Thrombectomy Catheter System to mechanically remove thrombus (blood
clots) in synthetic vessel grafts in hemodialysis patients. The X-SIZER
Thrombectomy Catheter uses a helical cutter and vacuum to engage, shear and
remove blood thrombus from the graft without trauma.
"The X-SIZER Thrombectomy System is an important addition to ev3's technologies
in the U.S. market," said James Corbett, ev3 president and chief executive
officer. "This device has been available for blood clot removal in coronary
arteries and saphenous vein grafts for several years in Europe and other parts
of the world. The effectiveness and convenience of the X-SIZER System will be
a welcome option for physicians in dialysis graft cases."
Hemodialysis, a procedure to remove metabolic wastes from the blood for
treating kidney failure, requires reliable long-term access to the patient's
blood vessels. In the United States, access is frequently accomplished with a
synthetic graft in the forearm that connects the brachial artery to the
brachial or cephalic vein. Over time, grafts can become narrowed by development
of abnormal vessel tissue growth or fibrosis, which can cause a clot to form
that blocks blood flow through the graft.
Clot-dissolving drugs injected into the graft are one treatment option.
However, safety and efficacy concerns recently prompted FDA limitations on some
drugs. As a result, use of some thrombolytic agents has declined, and more
physicians are turning to catheter devices to mechanically clear the thrombus
from the graft site. Further, mechanical thrombus removal generally provides
more immediate results than drugs. After thrombus removal, balloon angioplasty
is often performed to reopen the access graft.
About the X-SIZER Thrombectomy Catheter System
The X-SIZER System includes the thrombectomy catheter with a helical cutter, a
battery-powered control unit to operate the cutter and a vacuum bottle to
remove thrombus through the catheter lumen. As a fully contained device, the
ev3 system eliminates the need for large control consoles or power supplies
common with other mechanical thrombus removal systems.
Fast and easy device prep allows one person to set up the system in less than
two minutes. The physician can place the catheter in the graft site using any
standard 300cm, 0.014" guide wire, and use the same guide wire for both
thrombectomy and balloon angioplasty, speeding the procedure. All the
components necessary to perform the thrombectomy are provided with each device.
The X-SIZER Catheter has had CE Mark Approval for use in native coronary
vessels and saphenous vein grafts in Europe since 2002, and now has FDA 510(k)
market clearance for mechanical thrombus removal in synthetic dialysis grafts
in the United States.
About ev3
ev3 Inc., privately held and based in Plymouth, Minnesota, 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(TM), 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/ .
ev3, Protege, Protege GPS, SPIDER, SpideRX, X-SIZER, PLAATO, IntraCoil,
ParaMount, IntraStent, AqWire, Nitrex and Goose Neck are trademarks of ev3 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
Web site: http://www.ev3.net/