Medtronic secured an expanded CE mark for its Affera mapping and ablation system and Sphere-9 catheter to treat ventricular arrhythmias, including the life-threatening condition ventricular tachycardia. The device combines mapping with pulsed field and radiofrequency ablation to treat irregular heartbeats, and the company aims to expand this technology to treat ventricular tachycardia, where it has identified a significant unmet need in patient care. The CE mark expansion also covers premature ventricular complexes, which are extra heartbeats that briefly disrupt normal rhythm.
Ventricular tachycardia, which begins in the heart’s lower chambers, can lead to sudden cardiac arrest if sustained. Patients are typically treated with medication or may receive an implanted defibrillator to deliver pacing therapy or shocks to restore normal heart rhythm. Catheter ablation approaches to treat the condition have remained suboptimal, according to Medtronic.
The Food and Drug Administration recently granted breakthrough device designation for the Sphere-9 catheter in ventricular tachycardia, recognizing a need for new approaches to address the condition. This designation offers expedited review of the technology in patients with the condition. The Sphere VT key trial studying Sphere-9 for ventricular tachycardia is enrolling patients and will be used to support future approval of the device in the U.S.
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Field Medical, the PFA startup led by Steven Mickelsen, inventor of the Farapulse PFA technology that was sold to Boston Scientific, is also working to advance an ablation system to treat ventricular tachycardia. This competitive setting is shaping up to be a significant area of growth for medical device makers.
For patients living with ventricular tachycardia, the introduction of new catheter ablation tools offers a potential shift from relying solely on medication or shock-based defibrillators. The ability to physically alter the heart tissue to stop the rapid firing of electrical signals could reduce the frequency of dangerous episodes and the need for emergency medical intervention. While the technology is still in its early stages of adoption for this specific condition, the availability of more effective ablation options provides a path toward more stable long-term management for those at risk of sudden cardiac arrest.
Market expansion follows strong sales
Medtronic’s pulsed field ablation sales have grown quickly as physicians have adopted the treatment approach. Companies including Boston Scientific, Johnson & Johnson and Abbott are all battling for market share in pulsed field ablation. “Indication expansion to include ventricular arrhythmias unlocks another fast-growing market opportunity to keep building on our momentum,” Rebecca Seidel, Medtronic’s president of electrophysiology therapies, said in a statement.
