Clinical evidence supporting safe, effective, and predictable procedures to treat persistent atrial fibrillation (AF) with an all-in-one, dual-energy cardiac mapping and ablation catheter
Backed by over 100 publications1 and data from the first randomized controlled trial of pulsed field ablation (PFA) for persistent AF, the dual-energy Sphere-9™ radiofrequency (RF) and PFA catheter demonstrates proven safety, effectiveness, and procedural predictability.
Proven safety and effectiveness with superior efficiency compared to the RF control (p < 0.0001):
PVI + additional linear ablation with the Sphere-9™ catheter resulted in numerically higher long-term effectiveness compared to patients treated using a similar ablation strategy with the RF control (75% versus 68%, p = 0.21; N = 204 and N = 124, respectively).‡
Efficient lesion delivery:
‡ PVI + additional linear ablation includes at least one adjunctive ablation lesion set of the following: left atrial roof and posterior wall, mitral line, cavotricuspid isthmus (CTI) line.
Additional days with third case same-day discharge modeled over 1,000 lab days†,5
† Based on a discrete event simulation of 1,000 lab days using the SPHERE Per-AF trial data. These are not endpoints from the SPHERE Per-AF study but rather hypothetical modeling based on the data generated from the SPHERE Per-AF study.
Sphere-9™ catheter versus FARAWAVE™* PFA catheter for the treatment of patients with persistent AF using indirect treatment comparison methods
Indirect comparisons are not a substitute for head-to-head trials. Indirect comparisons have potential bias from unmeasured confounding factors, reduced statistical power, and imperfect matching of treatment effect modifiers.
77.4%
adjusted 12-month freedom from atrial arrhythmias in matched cohort of patients (Sphere-9™ catheter; n = 205)
vs.
63.5%
12-month freedom from atrial arrhythmias (FARAPULSE™* PFA system; n = 260; p = 0.003)
Even when adjusted
for differences in adjunctive ablation, results did not significantly change.◊
One Sphere-9™ catheter used in > 97% of SPHERE Per-AF procedures (n = 206/212)2
Up to three catheters used in ADVANTAGE AF Phase I cases
1.8%
adjusted major adverse event rate (Sphere-9™ catheter; n = 205)
vs.
2.3%
adjusted major adverse event rate (FARAWAVE™* PFA catheter; n = 260; p = 0.72)
Similar skin-to-skin procedure times despite more complex lesion sets performed with the Sphere-9™ catheter (p = 0.41)
§ OR 0.51 (95% CI:0.32–0.80), p = 0.003.
◊ MAIC-adjusted results for the sensitivity analysis performed to account for differences in adjunctive lesion sets: OR 0.44 (95% CI: 0.23–0.86), p = 0.017.
¶ Independent analysis from a single U.S. health system (three hospitals).
Streamline workflows and reduce variability; see how the Sphere-9™ catheter offers improved economic value compared to over-the-wire (OTW) PFA.10
Create lesions in less time11,12 with 10-times-larger effective surface area than standard irrigated ablation catheters.12
Remapping of patients treated with radiofrequency and the PULSE3 optimized waveform at 96 ± 43 days demonstrated durability in:
# All linear ablation target include left atrial roof line, mitral isthmus, and cavotricuspid isthmus.
Δ PFA was predominately used for LA roof line ablation, whereas other targets were ablated with various combinations of RF and PF energy.
Prospective, global, multicenter, observational post-market registry. The purpose of this study is to describe clinical performance and safety data in a broad patient population treated with the Affera™ platform.
Prospective, multicenter, interventional, nonrandomized clinical study. The safety and effectiveness of the Sphere-9™ catheter and Affera™ mapping and ablation system in patients undergoing redo ablation for symptomatic recurrent paroxysmal or persistent AF following a single ablation procedure.
Prospective, multicenter, nonrandomized, observational trial. Subjects will be treated with the Sphere-9™ catheter and Affera™ mapping and ablation system and followed through 36 months to evaluate the long-term effectiveness and safety of the Sphere-9™ catheter and Affera™ system in a post-approval setting for the treatment of drug refractory, recurrent, symptomatic, persistent AF.
Prospective, multicenter, nonrandomized, unblinded feasibility study. Adult subjects with recurrent, sustained, scar-related monomorphic ventricular tachycardia will be enrolled and treated with the Sphere-9™ catheter and Affera™ mapping and ablation system.
Prospective, multicenter, single-arm, unblinded pivotal clinical study. Adult subjects with recurrent, sustained, monomorphic ventricular tachycardia due to prior myocardial infarction will be enrolled and treated with the Sphere-9™ catheter and Affera™ system.
The Affera™ mapping and ablation system empowers physicians to accurately map and safely ablate with all-in-one HD mapping and dual-energy functionality.
The Sphere-9™ catheter provides HD mapping and dual-energy pulsed field (PF) and radiofrequency (RF) ablation in one zero exchange platform.
TM* Third-party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.
† Based on a discrete event simulation of 1,000 lab days using the SPHERE Per-AF trial data. These are not endpoints from the SPHERE Per-AF study but rather hypothetical modeling based on the data generated from the SPHERE Per-AF study.
‡ PVI + additional linear ablation includes at least one adjunctive ablation lesion set of the following: left atrial roof and posterior wall, mitral line, cavotricuspid isthmus (CTI) line.
§ OR 0.51 (95% CI:0.32–0.80), p = 0.003.
◊ MAIC-adjusted results for the sensitivity analysis performed to account for differences in adjunctive lesion sets: OR 0.44 (95% CI: 0.23–0.86), p = 0.017.
¶ Independent analysis from a single U.S. health system (three hospitals).
# All linear ablation target include left atrial roof line, mitral isthmus, and cavotricuspid isthmus.
Δ PFA was predominately used for LA roof line ablation, whereas other targets were ablated with various combinations of RF and PF energy.