InterShunt Technologies has initiated the EASE HF2 early feasibility study to assess the InterShunt percutaneous atrial shunt catheter (PAS-C) system, intended to alleviate symptoms of heart failure and enhance the quality of life for patients.
The first procedure in the US using the device was performed at The Christ Hospital Health Network in Cincinnati, Ohio, by Dr Sitaramesh Emani and the Structural Heart Intervention Team.
With plans to enrol 20 subjects across up to six US cities, the study targets individuals with heart failure with reduced ejection fraction (HFrEF), which is a condition characterised by the heart’s inability to pump effectively.
The PAS-C device aims to generate an opening between the upper chambers of the heart. It leverages a mechanical cutting technique that does not cause scarring and helps in the natural heart movement.
By reducing the pressure in the left atrium, the solution has the potential to alleviate symptoms.
It also safely removes a specific piece of tissue from the interatrial septum. This process establishes a shunt from the left to the right atrium, which helps to relieve the elevated pressure in the left atrium, thus minimising heart failure symptoms.
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By GlobalDataInterShunt Technologies CEO Harlee Sorkin said: “This first enrolment 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.
“Because the procedure leaves nothing behind in the heart, it avoids the risks of permanent implants and keeps future treatment options open.”
Heart failure is a major cause of hospitalisation for adults above 65 years old and is responsible for a significant portion of Medicare expenditure.
