Medtronic wins FDA breakthrough device tag for Sphere-9 ventricular arrhythmia catheter - MDT News | RalliesMedtronic wins FDA breakthrough device tag for Sphere-9 ventricular arrhythmia catheter
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MDT• FDA breakthrough designation for Sphere-9
- Medtronic received FDA Breakthrough Device Designation for its Sphere-9 catheter to treat ventricular arrhythmias.
- The designation supports an expedited U.S. regulatory pathway as the Sphere VT pivotal trial begins enrolling patients.
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