Adona’s Interatrial Shunt FIH Trial Completes Enrollment

June 17, 2025—Adona Medical, a Shifamed portfolio company that is developing a combined therapeutic–diagnostic cardiovascular implant, announced the completion of enrollment in the ATHENS-HF first-in-human study.

Adona stated that the study is evaluating the company’s chronically adjustable interatrial shunt with integrated bi-atrial pressure monitoring. The study enrolled patients with both preserved and reduced ejection fraction heart failure. The company anticipates presenting primary endpoint data from ATHENS-HF later this year.

According to the company, the device was implanted with 100% procedural success in 10 patients with heart failure. All patients had their shunt diameters successfully adapted both larger and smaller relative to an initial configuration. The impact of shunt size on the acute effects of the therapy were noted.

The company further reported that the majority of patients reached the 90-day follow-up timepoint after the original procedure. As planned, several months after the initial implantation, those patients received successful additional treatments to alter the shunt size. There have been no major procedural complications or site-reported major adverse cardiovascular and neurovascular events in the entire cohort to date.

Gagan Singh, MD, who serves as clinical advisor and proctor for the ATHENS-HF trial, commented on the device in the company’s press release

“During the initial cases, I have seen firsthand that the Adona shunt can be safely and reliably deployed, and that the bi-atrial sensors provide important insights into the hemodynamic condition of the patient and the immediate impact of the shunting therapy,” stated Dr. Singh. “Additionally, the early clinical experience preliminarily indicates the shunt diameter can be adjusted smaller or larger postimplantation, allowing for treatment tailored to patient-specific needs.”

Gregg W. Stone, MD, who is Coprincipal Investigator for the ATHENS-HF study, added, “A ‘one-size-fits-all’ technology may not be an optimal approach for all patients because heart failure is a diverse and evolving condition.”

Dr. Stone continued, “The ideal shunting solution would enable adaptive flow rates and provide hemodynamic feedback so that the shunt device could be adjusted to optimize therapy based on the patient’s needs, similar to calibrating for optimal medical therapy.”

He concluded, “The Adona interatrial shunt is designed to allow for tailored hemodynamic modulation in response to feedback from the integrated pressure sensors and the patient’s changing clinical status, offering promise to a broad patient population.”