Reported Saturday, Medtronic's Sphere-9 Catheter Receives FDA Breakthrough Device Designation For VT Treatment As Six-Month Data Shows 65.5% Freedom From VT Recurrence
Benzinga·04/27/2026 07:04:33
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- HRS late-breaking data: Interim results highlight six-month outcomes for patients treated with the Sphere-9 catheter for sustained monomorphic ventricular tachycardia (VT)
- Breakthrough device designation granted for use of the Sphere-9 catheter for treatment of VT; U.S. pivotal trial approved by FDA
- New at HRS: data show consistent durability for the Sphere-360 catheter across patient anatomies; Sphere-360 approved in CE Mark geographies
- First patients enrolled in Conquer-AF trial to evaluate the Sphere-9 catheter for repeat atrial fibrillation procedures
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