FDA says Medtronic can study Affera pulsed field ablation system for treating ventricular tachycardia

Medtronic (NYSE: MDT)+ announced today that the FDA approved an early feasibility study to evaluate its Affera system for treating VT.

The company can now evaluate the Affera mapping and ablation system with Sphere-9 catheter for treating sustained ventricular tachycardia (VT). This potentially life-threatening abnormal heart rhythm affects the lower chamber of the heart.

Medtronic designed Affera with Sphere-9 as an all-in-one, dual-energy pulsed field ablation (PFA) and radiofrequency (RF) ablation system. The high-density mapping catheter offers uses in cardiac electrophysiology ablation procedures. Several companies offer PFA technologies for treating AFib, another type of abnormal heart rhythm. The medtech giant now wants to move into VT as well.

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