Medtronic Affera System and Sphere-9 Catheter Receive CE Mark Expansion for Ventricular Tachycardia Ablation Treatment
Medtronic announced on Thursday that its Affera mapping and ablation system and Sphere-9 catheter received CE mark expanded indications for treating ventricular arrhythmias, including ventricular tachycardia. The FDA had previously granted breakthrough device designation to Sphere-9 to expedite its review in the United States. The Sphere VT pivotal trial is enrolling patients and will support a future US marketing application.
Quick Overview
- Medtronic announced on Thursday that its Affera Mapping and Ablation System and Sphere-9 catheter received CE mark expanded indications for the treatment of ventricular arrhythmias, including ventricular tachycardia—a potentially life-threatening rapid heartbeat.
- The U.S. Food and Drug Administration (FDA) recently granted Breakthrough Device Designation to the Sphere-9 catheter for the treatment of ventricular tachycardia, recognizing the urgent need for new treatment approaches in this area. This designation can provide an accelerated review pathway for the technology in eligible patients.
- Medtronic said the Sphere VT pivotal trial, which evaluates Sphere-9 for ventricular tachycardia, is currently enrolling patients, and its results will be used to support future U.S. marketing approval of the device.
In-Depth Analysis
Ventricular tachycardia originates in the lower chambers of the heart and, if sustained, can lead to sudden cardiac death.
Currently, patients are typically treated with medication or implantable defibrillators that use pacing or shocks to restore the heart's normal rhythm. Medtronic noted that catheter ablation options for this condition have previously been "unsatisfactory."
The company's Affera and Sphere-9 technology combines mapping capabilities with pulsed field ablation (PFA) and radiofrequency ablation to treat irregular heartbeats, including atrial fibrillation—a common arrhythmia that increases the risk of stroke. As physicians' adoption of PFA treatment grows, Medtronic's pulsed field ablation product sales have increased rapidly, with companies such as Boston Scientific, Johnson & Johnson, and Abbott also competing for market share in the PFA space.
Now, Medtronic plans to expand this technology to the treatment of ventricular tachycardia, believing there is significant unmet patient need in this area. The CE mark expansion also covers premature ventricular contractions—extra heartbeats that briefly disrupt the normal rhythm.
"Expanding the indication to ventricular arrhythmias opens another fast-growing segment for us and helps continue our current momentum," said Rebecca Seidel, president of Medtronic's electrophysiology therapies business, in a statement.
Field Medical, a PFA startup founded by Steven Mickelsen—the inventor of the Farapulse PFA technology sold to Boston Scientific—is also advancing an ablation system for the treatment of ventricular tachycardia.