Coronary Dilatation Catheter Scores with CE Mark


June 10, 2008

June 10, 2008 - OrbusNeich received CE Mark approval for the Scoreflex coronary dilatation catheter, a new product that extends OrbusNeich's balloon catheter portfolio.

Scoreflex is designed for use in focused force angioplasty, a technique in which the force resulting from balloon inflation in a stenotic lesion is concentrated at one or more locations within the stenosis. Published research has shown that focused force angioplasty is effective in resolving resistant stenosis, while reducing the frequency of complications with its use of gradual, low-pressure inflations.

The Scoreflex dual wire system creates a focal stress pattern to facilitate effective controlled plaque fracture at low-resolution pressure. In addition to its effective dilatation, Scoreflex has a low crossing profile and unbeatable trackability.

According to Rosli Mohd Ali, M.D., head of the Cardiology Department, National Heart Institute, Kuala Lumpur, Malaysia, "It also has the potential to achieve good angiographic results when compared to using a regular balloon in treating bifurcation lesions and lesions affecting small vessels."

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