Devices & Diagnostics

BSX gets FDA approval for ablation catheter, becomes third major player this week with ablation milestone

Boston Scientific (BSX) announced it has received U.S. Food and Drug Administration approval for its IntellaTip MiFi XP catheter and 501(k) clearance for its Zurpaz 8.5F steerable sheath, growing its EP mapping/ablation technology portfolio. This makes it the third major player–following both St. Jude Medical, which acquired Endosense, and GE, which invested in Acutus Medical–to […]

Boston Scientific (BSX) announced it has received U.S. Food and Drug Administration approval for its IntellaTip MiFi XP catheter and 501(k) clearance for its Zurpaz 8.5F steerable sheath, growing its EP mapping/ablation technology portfolio. This makes it the third major player–following both St. Jude Medical, which acquired Endosense, and GE, which invested in Acutus Medical–to have a big ablation technology milestone this week.

The catheter, compatible with the company’s Rhythmia Mapping System, has been approved for atrial flutter and uses mini-electrodes on its tip to provide information about location as well as help clinicians tell how mature lesions are and see whether tissue is viable. The steerable sheath is cleared to facilitate catheter placement for atrial flutter, atrial fibrillation and ventricular tachycardia.