InterShunt Enrolls First Patient in Groundbreaking Heart Failure Clinical Trial

Study Evaluates Innovative Left Atrial Shunt System for Improving Outcomes in HFpEF Patients

InterShunt Technologies has marked a pivotal milestone in heart failure research with the successful enrollment of the first patient in its EASE HF2 Early Feasibility Study, evaluating a novel device designed to alleviate symptoms in patients with heart failure with reduced ejection fraction (HFrEF). Unlike conventional therapies, this innovation offers a minimally invasive solution that creates a small interatrial opening to reduce excessive pressure in the heart—without leaving any implant behind. By using a mechanical cutting technique, the device minimizes the risk of scarring and enables the heart to maintain its natural motion, addressing a critical unmet need for patients who do not respond adequately to existing treatments.

The first U.S. procedure was performed at The Christ Hospital Health Network in Cincinnati, Ohio, by Dr. Sitaramesh Emani and the Structural Heart Intervention Team. The patient, who was discharged the following day with positive outcomes, represents a promising start to the trial. The EASE HF2 study focuses on assessing the safety and efficacy of this unique pressure-relief approach, potentially offering a new standard of care for HFrEF—a condition that affects millions globally and often results in frequent hospitalizations and diminished quality of life.

With no permanent implant left in the body, the device preserves future therapeutic options while avoiding complications associated with long-term implants. InterShunt’s approach exemplifies a growing trend in structural heart innovation—developing reversible, patient-centric interventions with broad applicability. If successful, the trial could pave the way for expanded treatment options that improve symptom management, reduce hospital readmissions, and enhance the overall care trajectory for heart failure patients.


MedTech Spectrum's Summary 
 
Breakthrough in Minimally Invasive Heart Failure Treatment: InterShunt’s device introduces a novel, implant-free method to reduce heart pressure in HFrEF patients, aiming to improve symptoms and quality of life without compromising future treatment options.
 
Successful Trial Kickoff Marks Clinical Progress: The first patient was successfully treated in the EASE HF2 Early Feasibility Study at The Christ Hospital, signaling early promise and strong procedural safety in a real-world clinical setting.
 
Potential to Redefine Care for HFrEF Patients: With millions affected by heart failure and limited options for non-responders to current treatments, this innovation could represent a significant shift toward safer, more adaptable therapies in structural heart care.