Dive Brief:
- Medtronic secured an expanded CE mark indication for its Affera mapping and ablation system and Sphere-9 catheter to treat ventricular arrhythmias, including ventricular tachycardia, a potentially life-threatening rapid heartbeat, the company said Thursday.
- 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. The designation offers expedited review of the technology in patients with the condition.
- The Sphere VT pivotal 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., Medtronic said.
Dive Insight:
Ventricular tachycardia, which begins in the heart’s lower chambers, can lead to sudden cardiac arrest if sustained.
Patients are 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,” Medtronic noted.
The company’s Affera and Sphere-9 technologies combine mapping with pulsed field and radiofrequency ablation to treat irregular heartbeats including atrial fibrillation, a common arrhythmia that raises the risk of stroke. Medtronic’s pulsed field ablation sales have grown quickly as physicians have embraced the treatment approach, and companies including Boston Scientific, Johnson & Johnson and Abbott are all battling for market share in PFA.
Now, Medtronic aims to expand use of the 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.
"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.
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.
