The FDA awarded Medtronic clearance for the company’s Euphora Semicompliant Balloon Dilatation Catheter. The device received European regulatory approval late last year.
The Euphora device is used to pre-dilate a lesion and to determine its nature, helping to choose which stent to place in its place.
The device uses the same re-designed shaft that was developed for the Medtronic NC Euphora noncompliant balloon dilatation catheter. Coupled with the thin balloon material, a tapered inner shaft, and mini-wrap, the device should help achieve a very low crossing profile.
Additionally, Medtronic has improved the packaging on the Euphora, adding EZ Pull Corners, reducing the container box, and making it easier to identify when on the shelf.