NEW YORK, March 1, 2021 /PRNewswire/ -- Axon Therapies, a Coridea portfolio company focused on addressing a root cause of heart failure, today announced the treatment of the first patient in the randomized, controlled REBALANCE-HF IDE feasibility trial. 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. Dr. Peter Fail, an interventional cardiologist at Cardiovascular Institute of the South in Houma, Louisiana, successfully treated the first patient using the novel therapy.
"Patients suffering from heart failure with preserved ejection fraction (HFpEF) represent a large, underappreciated clinical need in the market. We have few approved therapies to treat this population and many patients live with a diminished quality of life," commented Dr. Fail. "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."
Axon Therapies pioneered the minimally invasive SAVM procedure using the Satera System as a novel, frontline treatment that aims to stop heart failure progression and improve patient outcomes by addressing a root cause of the disease. In heart failure, the overactive sympathetic nervous system (SNS) 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 procedure selectively diminishes signals to the blood reservoir which allows blood volume to properly redistribute in the body, normalizes heart and lung pressures, and ultimately, reduces heart failure symptoms. Derived from a clinically safe procedure, the catheter-based SAVM preserves future therapy options, if needed, and retains the body's sympathetic response for emergency use.
"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," added Dr. Sanjiv Shah, national principal investigator of the REBALANCE-HF trial and Director of Research for the Bluhm Cardiovascular Institute at Northwestern University Feinberg School of Medicine in Chicago, IL.
The REBALANCE-HF study is a prospective, multi-center, randomized, sham controlled, double-blinded study enrolling 80 patients at up to 20 U.S. sites. 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 (GDMT) for heart failure. The study objective is to assess safety and effectiveness in HFpEF patients against a control. Subjects will be randomized 1:1 to either ablation of the right greater splanchnic nerve (GSN) using the Satera System (treatment cohort) or sham (control cohort) at the time of the procedure and followed 12 months post index procedure. Primary study endpoints include device or procedure-related serious adverse events (SAEs) and a reduction PCWP.
"This is an important milestone for our team and the heart failure market," commented Howard Levin MD, CEO of Axon Therapies. "HFpEF patients are in dire need of effective solutions, as limited approved therapies currently exist. With this trial we aim to demonstrate the value of the implant-free SAVM procedure with the Satera System."
The IDE trial follows promising first-in-human (FIH) data presented by Dr. Sanjiv Shah at the 2020 Annual Heart Failure Society (HFSA) meeting last fall. The FIH trial of 11 HFpEF patients 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.
About Axon Therapies, Inc. Axon Therapies, a portfolio company of proven medtech incubator Coridea, is focused on addressing a root cause of heart failure. Developed from a clinically proven procedure, splanchnic ablation for volume management (SAVM) using the Satera™ Ablation System enables targeted and sustained venodilation of the splanchnic vascular bed in order to restore volume balance and normalize key heart and lung pressures. The implant-free, catheter-based procedure aims to stop disease progression and improve symptoms in heart failure patients. Learn more at axontherapies.com.
About Cardiovascular Institute of the South Founded by Dr. Craig Walker in 1983, Cardiovascular Institute of the South (CIS) is a world-leader in preventing, detecting and treating cardiovascular and peripheral vascular disease. CIS offers a comprehensive heart and vascular program with expert physicians trained in many specialties, including internal medicine, nuclear cardiology, electrophysiology, lipid management, coronary artery disease, peripheral vascular disease, valve disease and interventional cardiovascular procedures. CIS has earned international acclaim as a pioneer of research, development and education, as well as an innovator in the treatment of peripheral vascular disease. With a dedicated team of more than 930 team members, CIS provides comprehensive cardiovascular care at 22 locations across Louisiana and Mississippi, with 10 telemedicine programs. CIS remains at the forefront of technology, providing the highest-quality, compassionate care. This mission has guided the institute for more than 37 years of excellence. For more information about CIS, call 1-800-425-2565 or visit www.cardio.com.