Adona Medical, a Shifamed portfolio company, has started a first-in-human (FIH) trial of its interatrial shunt for patients with heart failure in the US.

The California-based clinical-stage MedTech company is focused on developing  next-generation interatrial shunting and remote patient monitoring solutions for advanced heart failure patients.

The initial procedures involving the Adona shunt were carried out by George Khabeishvili at the Tbilisi Heart and Vascular Clinic in Georgia. US-based cardiologists Gagan Singh and Edris Aman provided support.  

Singh said: “The Adona implant represents the next-generation of shunt technology, designed for dynamic interatrial flow that can be modified based on patient-specific haemodynamic needs.

“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.”

The investigational Adona device features a shunt with a flow channel with adjustable geometry and an integrated bi-atrial pressure monitoring sensor.

It is designed to allow doctors to change their size post-implantation using a proprietary induction catheter, enabling more personalised treatment compared to traditional fixed-geometry-based shunts.  

Additionally, the device’s integrated sensors automatically capture pressure readings from both the left and right atria multiple times a day, without requiring patient interaction.

These daily readings can give physicians a clearer picture of a patient’s haemodynamic status, enhancing shunt therapy and allowing for better medical management.

Adona Medical co-founder and CEO Brian Fahey said: “Success with the initial clinical cases represents a significant milestone in our mission to offer improved solutions for the management of heart failure.

“We’re now one step closer to validating the potential benefits that the Adona technologies may offer to a vulnerable and suffering patient population.

“This was an enormous team effort, and I’d like to thank all of the Adona employees for their many contributions and our clinical collaborators for providing the valuable insights that have guided our incredible journey.”

In July 2024, Adona Medical raised $33.5m in Series C financing for interatrial shunt development. Prior to that, in 2022, the Shifamed portfolio company secured $37.5m in a Series B financing round.