Medtronic Launches Balloon Dilatation Catheter Following CE Mark

Wednesday, February 18, 2015

Source: FDA News

Medtronic has launched its Euphora Semicompliant Balloon Dilatation Catheter in Europe, following receiving of a CE mark, the Irish devicemaker said Monday. The first patient implant was performed in Newcastle, UK.

Richard Edwards, who performed the procedure, said Euphora’s low crossing profile and enhanced deliverability make it ideal for workhorse lesions and complex situations.

The device’s enhanced crossability can also create cut costs to cath labs by allowing for use of a single balloon to prep a lesion. This reduces the need for the “step up” technique — using several balloons of different sizes to cross the tight lesion and expand its size before treating with a stent, Medtronic said.

Separately, Medtronic said Monday that it received expanded FDA clearance for its Vertex Reconstruction System. Vertex lateral mass and pedicle screws can now be used to treat a variety of conditions in the posterior cervical spine, making it one of the first FDA-cleared systems in the U.S. for use of screws at the C1-C7 vertebrae, the company said.

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