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New balloon catheter receives CE approval

Medtronic : 02 November, 2007  (New Product)
Metronic’s Sprinter Legend Semicompliant Rapid Exchange Balloon Dilatation Catheter has received CE Mark approval for use in coronary angioplasty procedures.
The launch of the Catheter will begin immediately in Europe, Asia, the Middle East and Africa. The Sprinter Legend balloon Catheter is not approved for use in the USA.

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 1.25mm Zerofold balloon, and is exceptionally equipped to address the most difficult lesions in coronary angioplasty procedures. It is available in diameters of 1.25 to 4.0mm and lengths of 6, 10, 12, 15, 20, 25 and 30mm.

Dr Philip MacCarthy, consultant cardiologist at King’s College Hospital, London, UK, performed the first coronary angioplasty using the Sprinter Legend Balloon Catheter on October 24 2007, 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:

1.25mm balloon with Supercrosser Zerofold technology, available only from Medtronic – Exceptionally low profile 0.5mm (0.020inch) balloon featuring no wrapped material and no balloon shoulders for more powerful crossing in tightly occluded lesions.

Enhanced shaft – Push and track for easier lesion crossing; ideally suited for distal lesions. The low profile shaft also allows for the use of two balloons (1.25mm to 3.5mm) simultaneously in a 6 F guide Catheter (MGCID 0.070inch), known as the ‘kissing balloon’ technique.

Microbrite marker bands – Optimised cross and track with uncompromised radiopacity.

The Sprinter Legend balloon also features Medtronic’s renowned balloon technologies, including:

FasTrac tip – Low 0.041mm (0.016inch) 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 – 4.0mm 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 optimise 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.”

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