Healthcare Industry News:  Balloon catheter 

Devices Interventional Cardiology Regulatory

 News Release - November 1, 2007

Medtronic Receives CE Mark for Sprinter(R) Legend Balloon Catheter for Use in Angioplasty

Innovative Crossing Technologies Address Toughest Coronary Lesions

SANTA ROSA, Calif.--(HSMN NewsFeed)--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. (, 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.

Source: Medtronic

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