#USA #Clinical Trials #Heart Failure #Los Gatos #Adona Medical

Adona Medical's Pioneering Trial for Heart Failure

Adona Medical, part of the Shifamed portfolio, has announced a significant advancement in cardiovascular treatment with the completion of enrollment in their first-in-human trial, known as the ATHENS-HF study. This pioneering trial is focused on their innovative interatrial shunt designed for patients suffering from heart failure. Notably, the trial has successfully implanted the device in ten patients with every procedure achieving a 100% success rate.

The Adona Shunt: A Tailored Solution

The technology behind the Adona interatrial shunt is groundbreaking, as it allows for modifications post-implantation. This adaptability is crucial since heart failure presents as a varied and evolving medical condition. According to Dr. Gregg W. Stone, Co-Principal Investigator of the study, traditional one-size-fits-all approaches may not effectively meet every patient's unique requirements. The Adona shunt is designed to adjust the shunt size, thus providing a tailored, long-term management approach for individual patients.

This adjustable feature not only enhances the treatment but also integrates bi-atrial pressure monitoring, allowing medical professionals to gain real-time insights into the patient's hemodynamic condition, which is vital for optimizing therapy.

Success in the Clinical Trial

As part of the ATHENS-HF study, heart failure patients with both preserved and reduced ejection fractions were enrolled. The primary outcome of the study will be to evaluate the effectiveness of the device to modify shunt size based on each patient’s evolving condition. So far, at a 90-day follow-up, all initial patients have undergone additional modifications of their shunt sizes without any major complications reported. The results promise a safer, more effective management of heart failure, and further data from the trial will be presented later this year.

Enhancing Patient Care

The Adona shunt's design represents a significant advancement over existing shunt technologies, which typically have a fixed flow channel. With continuously adjustable flow rates and integrated daily pressure readings, physicians can have a more comprehensive understanding of each patient's needs, potentially leading to better-informed medical management. This feature could greatly transform how heart failure management is approached.

A Bright Future for Heart Failure Patients

Brian Fahey, Co-Founder and CEO of Adona Medical, expressed enthusiasm regarding the early results of the trial. By completing enrollment ahead of schedule, the company indicates solid groundwork for future advancements in heart failure technologies. Adona Medical is committed to moving forward with its clinical program, which may include next-generation devices in the near future.

Adona Medical is not yet commercially available in the U.S. or globally. However, its innovations signal a promising future for heart failure patients seeking personalized solutions. To learn more about Adona Medical and their groundbreaking work, please visit their website.

About Adona Medical

Adona Medical, based in Los Gatos, California, is a clinical-stage medical technology company on a mission to develop next-generation interatrial shunting and remote patient monitoring solutions. Supported by Shifamed, LLC, the company is focused on innovations that will enhance the lives of patients experiencing advanced heart failure. For more information, check out Adona Medical's official website.