Medtronic Receives Japanese Approval for Balloon Dilatation Catheter
Apr 5, 2004
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Medical appliance manufacturer Medtronic, Inc. (Minneapolis, MN, U.S.) announced that it has received approval from the Japanese Ministry of Health, Labor and Welfare to market its Sprinter(TM) Semi-Compliant Rapid Exchange Balloon Dilatation Catheter for use in coronary angioplasty procedures. The Sprinter balloon is immediately available in Japan in lengths of 6, 12, 15, 20, 25, and 30 mm and diameters of 1.5 to 4.0 mm.
"Due to the exceptional support of physicians in Japan who helped us in the development of this important product, we are well on track to provide physicians with the latest technology in balloon angioplasty," said Bill Hawkins, president of Medtronic Vascular. "The Sprinter balloon advances our offerings for procedures requiring semi-compliant balloons and provides an exceptional companion to Medtronic's BeStent2 Coronary Stent and other balloon, guide wire and catheter products available in Japan."
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 semi-compliant balloon, such as the Sprinter 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 semi-compliant balloon must navigate smoothly through tortuous and distal anatomy to reach the most difficult of lesions and provide the trackability and flexibility to pre-dilate a lesion for eventual stenting.
According to Medtronic, the Sprinter balloon has the following capabilities:
FasTrac(TM) Tip -- a new low-profile FasTrac tip that offers a combination of tip material and design to reach and treat even the most challenging lesions.
Fulcrum(TM) Balloon Material -- a highly supple material that aids navigation through tortuous and distal anatomy.
Supportive Shaft -- a low profile and responsive shaft that balances push with deliverability. In addition, the low profile shaft allows for the use of two balloons (1.5 to 3.5 mm) simultaneously in a 6F (French) guide catheter (minimum guide catheter internal diameter of 0.070"), known as the "kissing balloon" technique.
The Sprinter balloon received CE Mark approval in February and has been widely accepted throughout Europe.
"The Sprinter balloon represents a tremendous step forward in balloon technology and Medtronic has addressed all of the necessary requirements for an effective semi-compliant balloon," said Bernard Chevalier, M.D., Centre Cardiologique de Nord, Paris, France. "I am particularly impressed with the product's ability to perform the 'kissing balloon' technique and treat challenging lesions."
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