InterShunt Technologies Launches Groundbreaking Heart Failure Study with Innovative Device

InterShunt Technologies Begins Clinical Trials for Heart Failure Treatment

InterShunt Technologies, Inc., a pioneering medical device company, has formally initiated its groundbreaking clinical study called the EASE HF2 Early Feasibility Study. This research aims to investigate a novel device specifically designed to mitigate symptoms of heart failure and improve the quality of life for patients suffering from this disabling condition.

On June 30, 2025, the first patient in this U.S. clinical trial received the procedure at The Christ Hospital Health Network in Cincinnati, Ohio. Dr. Sitaramesh Emani, who leads the Structural Heart Intervention Team, performed the surgery. "We are excited to commence this study," expressed Dr. Emani. "The initial procedure went exceptionally well, and the patient was able to return home the following day in good health. This promising start fills us with hope for our ability to assist many more individuals facing heart failure."

The focus of the EASE HF2 study is patients diagnosed with heart failure with reduced ejection fraction (HFrEF). This condition is characterized by the heart's inability to pump efficiently, creating excessive pressure within the heart chambers. Traditional treatment methods have proven inadequate for many patients, and this innovative approach could offer a substantially enhanced alternative.

The device deployed in this study operates by creating a minute opening between the heart's upper chambers, alleviating the pressure that builds up due to heart failure. This technique uses a mechanical cutting method that prevents scarring, thus allowing the heart to maintain its natural movement throughout the procedure.

CEO Harlee Sorkin shared her thoughts on this significant milestone: "This first enrollment marks a major step forward for our team and those grappling with heart failure. We are profoundly grateful to the patient and their family, as well as the team at The Christ Hospital, for their invaluable support in making this possible. Importantly, since the procedure leaves nothing behind in the heart, it circumvents the issues associated with permanent implants, preserving other treatment options for patients down the line."

Understanding Heart Failure

Heart failure is the primary reason for hospital admissions among adults aged 65 and older, accounting for as much as 5% of Medicare expenditures. Many patients do not achieve sufficient relief from existing medications. Research indicates that reducing pressure in the left atrium of the heart can improve symptoms and enhance the quality of life for certain patients.

InterShunt Technologies, Inc. is actively working on a unique catheter system designed to securely capture and excise a specific piece of tissue from the interatrial septum. This action results in a left-to-right atrial shunt, which effectively alleviates raised left atrial pressure, thereby reducing symptoms in heart failure patients. The mechanical system emphasizes safety and user-friendliness and is notable for being the only interatrial shunting device that avoids the use of implants or energy.

The EASE HF2 study is set to enroll up to 20 patients across six various U.S. sites. This innovative strategy aims to lower elevated left atrial pressure, which could significantly improve symptoms, such as breathlessness, in individuals diagnosed with HFrEF.

The Christ Hospital Health Network's Commitment

Established for over 135 years, The Christ Hospital Health Network provides comprehensive care through its network of acute care facilities and outpatient centers in the Greater Cincinnati region. With a team of over 1,300 physicians and 7,200 employees, the network's mission focuses on enhancing community health by ensuring exceptional health outcomes at affordable costs. This dedication has earned the network recognition, such as being named the #1 hospital in the Cincinnati Region by U.S. News & World Report and featured in Newsweek's list of the World’s Best Hospitals in 2025. Its Lindner Research Center is notable for participating in over 1,200 clinical trials, establishing itself as a leader in cardiovascular medicine by pioneering numerous advanced techniques.

As InterShunt Technologies moves forward with this compelling study, the potential for improved heart failure treatments brings renewed hope to countless patients and families impacted by this serious health issue.