Adona Medical Begins FIH Study of Interatrial Shunt for Heart Failure

October 27, 2024—Adona Medical, a Shifamed portfolio company, announced the commencement of its first-in-human (FIH) study of the Adona interatrial shunt in patients with heart failure. The adjustable interatrial shunt with integrated bi-atrial pressure monitoring aims to deliver a more personalized lifetime approach to heart failure management, stated the company.

The initial procedures in the FIH study were performed by George Khabeishvili, MD, at Tbilisi Heart and Vascular Clinic in Tbilisi, Republic of Georgia, and supported by heart failure experts from the United States, Gagan Singh, MD, and Edris Aman, MD.

According to the company, the Adona shunt features a flow channel with an adjustable geometry that can be made larger or smaller postimplantation via the use of an induction catheter. This configurability is intended to potentially allow for more individualized treatments compared to shunt devices with a flow passage with one fixed geometry.

In addition, integrated sensors are designed to capture pressure readings from both the left and right atria multiple times per day without requiring patient interaction. These daily readings are intended to provide physicians with a more complete understanding of a patient’s hemodynamic status and enable more informed medical management, noted Adona Medical.

“I am incredibly excited to be involved in the initial procedures for this groundbreaking technology,” commented Dr. Singh in the company’s press release. “The Adona implant represents the next-generation of shunt technology, designed for dynamic interatrial flow that can be modified based on patient-specific hemodynamic needs.”

Dr. Singh, who is Clinical Cardiovascular Research Unit Director at the University of California at Davis in Sacramento, California, continued, “Heart failure is not a static condition but requires lifetime management. The combination of adjustable shunt size and atrial pressure measurement represents a huge leap forward in device therapy solutions.”