Axon’s Satera System for Splanchnic Ablation for Volume Management Studied in REBALANCE-HF Feasibility Trial

March 22, 2023—Axon Therapies announced 6-month results from the roll-in cohort of the REBALANCE-HF investigational device exemption (IDE) feasibility trial of the company’s Satera ablation system used in splanchnic ablation for volume management (SAVM) to treat the root cause of heart failure (HF). This implant-free, catheter-based, outpatient ablation procedure is a novel frontline therapy that aims to rebalance volume distribution for patients experiencing HF with preserved ejection fraction (HFpEF), noted the company.

The findings were presented by Marat Fudim, MD, at THT 2023, the second annual Technology and Heart Failure Therapeutics conference held March 20-23 in Boston, Massachusetts.

The company also announced it expects the REBALANCE-HF trial to reach full enrollment of approximately 120 patients by the end of March, with full study results anticipated in 2024. Findings from the feasibility trial will inform the pivotal trial, which is expected to begin in late 2023.

According to the company, the randomized controlled REBALANCE-HF trial is designed to evaluate the safety and efficacy of the SAVM procedure in HFpEF patients. The primary endpoints of the prospective multicenter trial include clinical improvements in pulmonary capillary wedge pressure (PCWP) with exercise and patient quality-of-life metrics.

The roll-in cohort for this early analysis includes 26 patients who successfully underwent the SAVM procedure with a strong safety profile and showed a sustained improvement in PCWP with exercise. Additionally, improvements in functional capacity, symptoms, and overall health status that had been seen at 1 month were extended to 6 months.

“The SAVM procedure offers an exciting option to treat an underlying cause of HF& n a patient population that currently has limited treatment options available,” commented Dr. Fudim in the company’s press release. “Although early data, it is promising to see positive patient benefits sustained for 6 months, and we look forward to further demonstrating how SAVM has the potential to benefit the HFpEF patient population.” Dr. Fudim is an advanced HF specialist at Duke University Medical Center in Durham, North Carolina.

The company advised that the results were consistent with early REBALANCE-HF data for the SAVM therapy. Those findings were presented at the European Society of Cardiology’s Heart Failure Association 2022 conference held May 21-24 in Madrid, Spain, and published by Dr. Fudim et al online in European Journal of Heart Failure.

Sanjiv Shah, MD, National Principal Investigator for REBALANCE-HF, stated in the press release, “HFpEF encompasses several distinct phenotypes, and recent studies have indicated that this diversity may impact clinical outcomes. For that reason, we opted for a larger feasibility trial to identify potential responder groups at an earlier stage. As we continue to collect follow-up data for the REBALANCE-HF feasibility trial, this information will help guide the final pivotal trial design.” Dr. Shah is an advanced HF specialist and the Director of Research for the Bluhm Cardiovascular Institute at Northwestern University Feinberg School of Medicine in Chicago, Illinois.