Shifamed's Adona Medical initiates first-in-human shunt study

Nov 02, 2024

October 28, 2024 By Sean Whooley

Dr. George Khabeishvili performed the first cases in a study at the Tbilisi Heart and Vascular Clinic in the Republic of Georgia. U.S. heart failure experts Dr. Gagan Singh and Dr. Edris Aman supported the initial cases.

Adona Medical utilizes nitinol’s shape memory properties in its adjustable, bi-atrial-sensing heart shunt. The Adona device includes a shunt with a flow channel that offers an adaptable geometry capable of growing larger or minimizing at any time post-implant. This can help optimize shunting flow or dose for patient needs at the time of the initial procedure. It can then adjust as the patient’s condition evolves over time.

Los Gatos, California-based Adona integrated sensors into the shunt to capture pressure readings from both the left and right atria multiple times per day without requiring patient interaction. These readings deliver a more complete picture of a patient’s hemodynamic status.

The company raised $33.5 million earlier this year to further support its technology.

“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,” said Brian Fahey, Adona Medical co-founder and CEO. “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.”

Filed Under: Cardiac Implants, Cardiovascular, Clinical Trials, Implants, Patient Monitoring, Structural Heart Tagged With: nitinol, Nitinol Devices & Components