Medtronic announced on April 25 promising clinical milestones for its Affera family of cardiac arrhythmia treatment technologies, including the Sphere-9 and Sphere-360 catheters, at the Heart Rhythm Society Annual Meeting. The company also reported enrollment of the first patient in a new global trial evaluating these devices in a broader atrial fibrillation (AFib) population.
These developments are significant as they address ongoing needs in treating complex heart rhythm disorders such as ventricular tachycardia (VT) and AFib. Catheter ablation is an established therapy, but innovation has been limited, leaving many patients with suboptimal outcomes.
According to Medtronic, early feasibility data from U.S. centers showed that 65.5% of patients treated with the Affera mapping and ablation system and Sphere-9 catheter remained free from VT recurrence six months after ablation. The U.S. Food and Drug Administration granted Breakthrough Device Designation to the Sphere-9 catheter for VT treatment to expedite regulatory review.
“Physicians urgently need better tools for VT that are safe, effective, and increase procedure efficiency, so it’s exciting to see sustained outcomes for ischemic patients treated with the Affera mapping and ablation system and the Sphere-9 catheter after six months,” said Vivek Reddy, M.D., Director of Cardiac Arrhythmia Services at Mount Sinai Health System in New York City. “Moving this research forward to the IDE trial and expanding the patient population to include non-ischemic patients are positive next steps for VT patients.”
A sub-analysis from the European Sphere-360 study demonstrated complete lesion durability in AFib procedures among patients with left common pulmonary veins. Previously reported data showed high rates of lesion durability per vein (98%) and per patient (93%) through invasive remapping at 75 days post-ablation.
Medtronic also launched Conquer-AF, a multi-center study enrolling participants across the United States, Europe, and Australia who have recurrent paroxysmal or persistent AFib after prior ablation procedures.
“Our robust clinical research program reinforces our commitment to advancing safe, effective, and efficient therapies to help physicians treat a wide range of cardiac arrhythmias and improve patients’ lives,” said Khaldoun Tarakji, M.D., MPH, vice president and chief medical officer for Cardiac Ablation Solutions at Medtronic. “The encouraging results shown in this VT study underscore the versatility of the Sphere-9 catheter… With the Sphere-360 catheter, consistent durability across a wide range of patient anatomies is good news for patients and for physicians’ workflow.”
The company reports that its catheters are approved or under investigation in several regions including Europe—where Sphere-360 received CE Mark approval—and ongoing trials continue worldwide.
