Axon Therapies Splanchnic Ablation for Volume Management Evaluated in Early Data From REBALANCE-HF IDE Trial

May 25, 2022—Axon Therapies announced that early results from a roll-in cohort for its REBALANCE-HF feasibility investigational device exemption trial support the safety and efficacy of the splanchnic ablation for volume management (SAVM) procedure, signaling clinical improvements in pulmonary capillary wedge pressure (PCWP) with exercise and patient quality of life.

The data were presented by Marat Fudim, MD, at European Society of Cardiology (ESC)’s Heart Failure Association 2022 conference held May 21-24 in Madrid, Spain, and simultaneously published online in European Journal of Heart Failure.

SAVM with the Axon ablation system allows for targeted ablation of the overactive sympathetic nervous system. In heart failure patients with preserved ejection fraction, the implant-free, catheter-based procedure aims to restore volume balance, stop disease progression, and improve heart failure symptoms.

According to the company, the prospective, multicenter, randomized, sham-controlled, double-blinded REBALANCE-HF study is enrolling up to 80 patients at up to 20 sites in the United States and is designed to assess the safety and efficacy of the SAVM procedure using the Axon ablation catheter.

The REBALANCE-HF data presented at ESC were from a single-arm, open-label, roll-in cohort of 18 patients for interim analysis.

Axon Therapies noted that the findings require additional confirmation but are promising; all patients were treated successfully, and three nonserious device-related adverse events were reported (heart failure decompensation requiring an emergency room visit, transient hypertension during the procedure, and back pain after the procedure). Improvements included PCWP with exercise, functional capacity, symptoms, and overall health status.

As indicated in the press release, the key results were:

• A significant reduction in PCWP at 20 W and peak exercise at 1 month (P = .007 and P = .013, respectively).
• An improvement in 33% of patients of at least one New York Heart Association class compared to baseline at 1 month (P < .01).
• A significant improvement in Kansas City Cardiomyopathy Questionnaire (22.1 points at 1 month, P < .01; 18.3 points at 3 months, P < .01).

“The SAVM procedure offers a novel approach to potentially improving outcomes in patients suffering from heart failure by reducing sympathetic nerve activity to restore volume balance within the circulation,” commented National Principal Investigator Sanjiv Shah, MD. “The early data from the REBALANCE-HF trial demonstrate the potential promise and importance of managing volume shifts in this underserved patient population.” Dr. Shah is Director of Research for the Bluhm Cardiovascular Institute at Northwestern University Feinberg School of Medicine in Chicago, Illinois.

Axon Therapies CEO Chad Hoskins noted that the company plans to complete enrollment later this year and share the full results of REBALANCE-HF next year. A pivotal trial is anticipated in 2023.