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Adona Medical Initiates First-in-Human Study of Novel Interatrial Shunt for Heart Failure

• Adona Medical has commenced a first-in-human study of its innovative interatrial shunt for heart failure patients, marking a significant step in heart failure treatment. • The study, conducted at the Tbilisi Heart and Vascular Clinic, involves the use of Adona's adjustable shunt with bi-atrial pressure monitoring capabilities. • Adona's device utilizes nitinol's properties to adapt shunt flow, potentially optimizing treatment as patient conditions evolve post-implantation. • The integrated sensors in the shunt provide comprehensive hemodynamic data, offering a more complete understanding of the patient's condition.

Adona Medical, a Shifamed portfolio company, has announced the successful first-in-human use of its novel interatrial shunt in patients suffering from heart failure. The initial cases were performed by Dr. George Khabeishvili at the Tbilisi Heart and Vascular Clinic in the Republic of Georgia, with support from U.S. heart failure experts Dr. Gagan Singh and Dr. Edris Aman.
The Adona device is designed with a unique adjustable, bi-atrial-sensing heart shunt that leverages nitinol's shape memory properties. This allows the shunt's flow channel to adapt its geometry post-implantation, either increasing or decreasing in size to optimize shunting flow based on the patient's evolving needs. This adaptability is crucial for managing the complex and dynamic nature of heart failure.

Integrated Bi-Atrial Pressure Monitoring

One of the key features of the Adona shunt is its integrated sensors, which capture pressure readings from both the left and right atria multiple times per day without requiring any patient interaction. This continuous monitoring provides a more complete picture of the patient's hemodynamic status, enabling clinicians to make more informed decisions regarding treatment adjustments.

Clinical Significance and Future Implications

"Success with the initial clinical cases represents a significant milestone in our mission to offer improved solutions for the management of heart failure," said Brian Fahey, Adona Medical co-founder and CEO. "We're now one step closer to validating the potential benefits that the Adona technologies may offer to a vulnerable and suffering patient population."
Adona Medical raised $33.5 million earlier this year to further support the development and clinical evaluation of its technology. The ongoing first-in-human study will provide critical data on the safety and efficacy of the Adona interatrial shunt, potentially paving the way for a new treatment option for heart failure patients.
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Reference News

[1]
Shifamed's Adona Medical initiates first-in-human interatrial shunt study - MassDevice
massdevice.com · Oct 28, 2024

Adona Medical initiated the first-in-human study of its novel interatrial shunt, featuring integrated bi-atrial pressure...

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