01.11.2007 12:00:00
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Medtronic Receives CE Mark for Sprinter(R) Legend Balloon Catheter for Use in Angioplasty
Medtronic, Inc. (NYSE:MDT), today announced that it has received CE Mark
approval for the Sprinter® Legend
Semicompliant Rapid Exchange Balloon Dilatation Catheter for use in
coronary angioplasty procedures. The launch of the product will begin
immediately in Europe, Asia, the Middle East and Africa. The Sprinter
Legend balloon catheter is not approved for use in the United States.
During angioplasty procedures, a balloon catheter is threaded through
the femoral artery to the lesion and inflated, compressing the plaque
associated with coronary artery disease against the vessel wall and
restoring blood flow. A semicompliant balloon, such as the Sprinter
Legend balloon, is used to open the blood pathway in coronary arteries
before a stent is implanted. As one of the first devices typically used
in a coronary stenting procedure, a semicompliant balloon must navigate
smoothly through tortuous and distal anatomy to reach the most difficult
of lesions and provide the trackability and flexibility to predilate a
lesion for eventual stenting.
The Sprinter Legend Balloon Catheter provides the latest innovations in
balloon technology, including the unique 1.25 mm Zerofold balloon, and
is exceptionally equipped to address the most difficult lesions in
coronary angioplasty procedures. It is available in diameters of 1.25 –
4.0 mm and lengths of 6, 10, 12, 15, 20, 25 and 30 mm.
Dr. Philip MacCarthy, consultant cardiologist at King’s
College Hospital, London, United Kingdom, performed the first coronary
angioplasty using the Sprinter Legend Balloon Catheter on October 24,
during a live case at the Transcatheter Cardiovascular Therapies (TCT)
conference.
"The Sprinter Legend delivers on its promise
as a high performing balloon, especially from a push and crossing
perspective,” said Dr. MacCarthy. "As
I continue to treat more challenging lesions, Sprinter Legend has taken
balloon innovation to the next level.”
Important features of the Sprinter Legend Balloon Catheter include:
1.25 mm balloon with Supercrosser Zerofold technology, available only
from Medtronic – Exceptionally low profile
0.5 mm (0.020”) balloon featuring no
wrapped material and no balloon shoulders for more powerful crossing
in tightly occluded lesions.
Enhanced shaft – Superb push and track for
easier lesion crossing; ideally suited for distal lesions. The low
profile shaft also allows for the use of two balloons (1.25 mm to 3.5
mm) simultaneously in a 6 F guide catheter (MGCID 0.070”),
known as the "kissing balloon”
technique.
Microbrite marker bands – Optimized cross
and track with uncompromised radiopacity.
The Sprinter Legend balloon also features Medtronic’s
renowned balloon technologies, including:
FasTrac tip – Low 0.041 mm (0.016”)
lesion entry profile and pioneering tip material are designed to reach
and treat even the most challenging lesions.
MiniWrap folding – Proprietary process
provides low profile shoulders and tight rewrap on the 1.50 –
4.0 mm balloon offering.
Selective Dura-Trac coating – Excellent
lubricity during tracking and position retention during inflation.
The Sprinter Legend Semicompliant Balloon Catheter enhances Medtronic’s
balloon portfolio, which includes the Sprinter OTW and NC Sprinter
Noncompliant Balloon Catheter, designed to provide the precision and
performance expected in a post-stent dilatation balloon and to optimize
stenting results in the era of drug-eluting stents.
"Medtronic is committed to innovation in the
field of interventional cardiology, and the Sprinter Legend Balloon
Catheter underscores the depth of that commitment with its innovative
crossing technologies,” said Rob ten Hoedt,
vice president of the CardioVascular business for Medtronic in Western
Europe. "The Sprinter Legend balloon
introduces a new level of balloon technology to assist our customers in
treating their most difficult clinical challenges.” About Medtronic
Medtronic, Inc. (www.medtronic.com),
headquartered in Minneapolis, is the global leader in medical technology –
alleviating pain, restoring health, and extending life for millions of
people around the world.
Any forward-looking statements are subject to risks and uncertainties
such as those described in Medtronic’s Annual
Report on Form 10-K for the year ended April 27, 2007. Actual results
may differ materially from anticipated results.
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