Medtronic's Next Frontier:
FDA Clears Study for Dual-Energy Catheter to Treat Dangerous Heart Condition

Medtronic has secured FDA approval to begin studying its Affera mapping and ablation system alongside the Sphere-9 catheter in treating sustained ventricular tachycardia (VT), a potentially life-threatening heart rhythm disorder. This early feasibility trial will focus on patients whose VT is linked to scarring from a previous heart attack. The Affera system combines two cutting-edge technologies—pulsed field ablation (PFA) and radiofrequency (RF) ablation—paired with high-density mapping to improve the precision and efficiency of ablation procedures.

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Ventricular tachycardia is a rapid and irregular heartbeat originating in the heart’s lower chambers, often following heart attacks or in cases of heart failure. Current treatments involve medications or implantable defibrillators to restore normal heart rhythms. Medtronic's innovative approach, according to its cardiac ablation solutions chief medical officer Khaldoun Tarakji, could streamline the process, making it more effective and less time-consuming by eliminating the need for multiple catheters during RF ablation procedures.

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The study will evaluate safety and efficacy, including the rate of serious adverse events and the effectiveness of ablation on targeted VT. Participants will be monitored for six months post-procedure to determine long-term results. Medtronic's Sphere-9 catheter, already approved in Europe for atrial fibrillation treatment, could soon be available in the U.S. pending FDA approval for treating arrhythmia, further expanding its impact.