Dive Brief:
- Medtronic has received Food and Drug Administration approval to study its Affera mapping and ablation system and Sphere-9 catheter to treat sustained ventricular tachycardia, an abnormal rhythm of the heart’s lower chambers.
- The early feasibility trial will assess the ablation treatment in patients who suffer from the disorder due to scarring from a prior heart attack, Medtronic said in its announcement last week.
- The Affera system and Sphere-9 catheter combine pulsed field ablation (PFA) and radiofrequency (RF) ablation technologies with high-density mapping in a dual-energy approach to cardiac electrophysiology ablation procedures.
Dive Insight:
Ventricular tachycardia (VT), which causes the heart to beat abnormally fast, is a potentially life-threatening condition that can occur after a heart attack or in combination with other forms of heart disease such as heart failure.
Patients are treated with medications or may receive an implanted defibrillator to deliver pacing therapy or shocks to restore normal heart rhythm. Medtronic’s approach aims to improve on current catheter ablation procedures to treat the condition.
“Approved treatments for VT involve only RF energy and require physicians to use multiple mapping and ablation catheters with often long, inefficient procedure times,” Khaldoun Tarakji, chief medical officer for Medtronic’s cardiac ablation solutions business, said in a statement. “PFA technology and the innovative Sphere-9 design could have a significant impact on patient care.”
The primary endpoints in Medtronic’s feasibility study include rate of device- or procedure-related serious adverse events and acute effectiveness at ablating the targeted VT. Patients will be followed for six months after the procedure.
“Physicians need better tools to treat VT safely and effectively, and early feasibility research is a positive step toward determining potential new options,” Vivek Reddy, director of cardiac arrhythmia services for the Mount Sinai Health System in New York City, said in Medtronic’s statement.
The Sphere-9 catheter received Europe’s CE mark in 2023 for the treatment of persistent atrial fibrillation, another form of abnormal heart rhythm in which the heart’s chambers beat out of sync. Medtronic earlier this year submitted an application to the FDA for U.S. approval of the catheter to treat patients with AFib, CEO Geoff Martha said on the company’s earnings call in August.