First Patient Treated in the REBALANCE-HF IDE Feasibility Trial of Axon Therapies’ Satera Ablation System

March 1, 2021—Axon Therapies, a Coridea portfolio company, announced the treatment of the first patient in the randomized controlled REBALANCE-HF feasibility trial conducted under an investigational device exemption (IDE). The trial is designed to provide safety and efficacy data for Axon’s splanchnic ablation for volume management (SAVM) procedure using the Satera ablation system.

According to the company, the REBALANCE-HF study is a prospective, multicenter, randomized, sham-controlled, double-blinded study enrolling 80 patients at up to 20 sites in the United States. Patient enrollment criteria include chronic heart failure patients with an ejection fraction of ≥ 50%, elevated pulmonary capillary wedge pressure (PCWP) with exercise, and stable guideline-directed medical therapy for heart failure.

The study’s objective is to assess safety and effectiveness in patients with heart failure with preserved ejection fraction (HFpEF) against a control. The study patients will be randomized 1:1 to either ablation of the right greater splanchnic nerve using the Satera system (treatment cohort) or sham (control cohort) at the time of the procedure and followed 12 months after the index procedure. Primary study endpoints include device- or procedure-related serious adverse events and a reduction in PCWP.

Peter Fail, MD, an interventional cardiologist at Cardiovascular Institute of the South in Houma, Louisiana, treated the first patient using the SAVM therapy.

“Patients suffering from HFpEF represent a large, underappreciated clinical need in the market,” commented Dr. Fail in the company’s press release. “We have few approved therapies to treat this population, and many patients live with a diminished quality of life.”

Dr. Fail continued, “Ablation of the greater splanchnic nerve using the Satera system offers a novel approach to restore balance to the sympathetic nervous system, a key driver of worsening heart failure, and potentially slow disease progression. We’re excited to participate in the REBALANCE-HF trial and further evaluate the therapy.”

According to Axon Therapies, the company pioneered the minimally invasive SAVM procedure using the Satera system as a frontline treatment to stop heart failure progression and improve patient outcomes by addressing a root cause of the disease. Catheter-based SAVM preserves future therapy options (if needed) and retains the body’s sympathetic response for emergency use.

In heart failure, the overactive sympathetic nervous system remains “on” for extended periods of time, which overstresses the body’s main blood reservoir, causing high pressures in the heart and lungs. Elevated pressures are a primary limiting factor in exercise and may exasperate acute decompensation, leading to heart failure hospitalizations. By unilaterally ablating the neural pathway, the implant-free SAVM procedure selectively diminishes signals to the blood reservoir, which allows blood volume to properly redistribute in the body, normalizes heart and lung pressures, and reduces heart failure symptoms, noted the company.

Sanjiv Shah, MD, who is National Principal Investigator of the REBALANCE-HF trial, stated in the announcement, “The SAVM procedure allows selective venodilation, improved venous compliance, and ultimately aims to restore appropriate volume balance within the circulation to reduce heart and lung pressures and slow disease progression.” Dr. Shah is Director of Research for the Bluhm Cardiovascular Institute at Northwestern University Feinberg School of Medicine in Chicago, Illinois.

The IDE trial follows promising first-in-human data presented by Dr. Shah at the 2020 Heart Failure Society of America annual meeting last fall. The first-in-human trial of 11 patients with HFpEF met all primary safety and efficacy endpoints and showed significant improvement in patient quality-of-life metrics, functional capacity, and a reduction in NT-proBNP, a key indicator of heart failure status, advised the company.