
Shifamed‘s Adona Medical announced today that it completed enrollment in the ATHENS-HF first-in-human study of its interatrial shunt.
The company initiated the study last year, announcing the successful first-in-human use of the novel shunt in patients with heart failure in October.
Adona Medical utilizes nitinol’s shape memory properties in an adjustable, bi-atrial-sensing heart device. The device features 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 to provide tailored hemodynamic modulation.
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.
Nitinol innovation: Download our free special report featuring coverage of Adona Medical and other medical device OEMs
Update on the Adona Medical trial
Today, the company says investigators successfully implanted the shunt in 10 patients with heart failure with 100% procedural success. All patients had their shunt diameters successfully adapted, both larger and smaller relative to an initial configuration.
ATHENS-HF enrolled patients with both preserved and reduced ejection fraction heart failure. Adona said the majority of patients reached the 90-day follow-up timepoint after the original procedure. As planned, they underwent additional treatments to alter the shunt size several months after the initial implantation.
Adona reports no major pocedural complications or site-reported major adverse cardiovascular and neurovascular events (MACNE) in the entire cohort to date.
“Completing enrollment in our first-in-human study ahead of schedule marks a pivotal milestone that highlights our team’s ability to execute upon our ambitious mission,” stated Brian Fahey, co-founder and CEO of Adona Medical. “The strong early results are a clear indicator that we’re building a platform that has the potential to transform heart failure management. We are well-positioned for our next phases, with a plan to advance our clinical program with the evaluation of next-generation devices later this year.”