InterShunt Technologies, Inc., a medical device company focused on developing minimally invasive treatments for heart failure, has officially kicked off its latest clinical study, the EASE HF2 Early Feasibility Study, which is evaluating a device designed to reduce heart failure symptoms and improve quality of life.
The first U.S. procedure utilizing InterShunt’s technology was performed by Dr. Sitaramesh Emani and the Structural Heart Intervention Team at The Christ Hospital Health Network in Cincinnati, Ohio. “We’re excited to get this study started,” said Dr. Emani. “The first procedure went smoothly, and the patient went home the next day feeling well. It’s an encouraging start, and we’re hopeful this treatment can help many more people.”
The study focuses on patients with heart failure with reduced ejection fraction (HFrEF), a condition where the heart does not pump as well as it should, leading to excessive pressure within the heart. Current treatments do not work for everyone, and this new approach could offer a better option.
The device works by creating a small opening between the heart’s upper chambers to relieve pressure that builds up in heart failure. It uses a mechanical cutting method that avoids scarring and allows the heart to move naturally.
“This first enrollment is a big step for our team and for people living with heart failure. We are incredibly thankful to the patient, their family, and the team at The Christ Hospital for making this possible.” said Harlee Sorkin, CEO of InterShunt Technologies. “Because the procedure leaves nothing behind in the heart, it avoids the risks of permanent implants and keeps future treatment options open.
