Occlutech launches FROST-HF study of heart failure device
pharmafile | March 14, 2023 | News story | Research and Development |
Occlutech has announced that it has recruited its first patient in the FROST-HF study, which aims to investigate the company’s atrial flow regulator (AFR) device to treat patients with heart failure.
The study will include patients with either preserved ejection fraction (HFpEF) or reduced ejection fraction (HFrEF), assessing the company’s AFR device for its safety and effectiveness.
Occlutech has shared that AFR is a small device which can be used for placing a shunt between the two upper chambers of the heart in order to open and control its size.
The FROST-HF study will be randomised, double-blinded, multi-centre and sham-controlled, with the aim of gathering data on the safety and efficacy of the device. It is intended that the data found in this trial will be used to support a marketing application to the FDA, meaning the device could be used commercially in the US.
The trial aims to enrol 588 heart failure patients, with an additional roll-in group of 110 patients, across the US, Europe and Canada.
Dr Gregg W Stone, FROST-HF executive committee co-chair and professor at Icahn School of Medicine at Mount Sinai Heart Health System, New York, commented: “The FROST-HF trial will contribute significantly to our knowledge regarding the safety and effectiveness of inter-atrial shunting in patients with heart failure, with both preserved and reduced left ventricular ejection fraction. In addition, testing two different sizes of inter-atrial shunts in this study will provide unique insights, and potentially signal how different magnitudes of inter-atrial shunting may contribute to the clinical benefit.”
Dr Stefan Anker, FROST-HF executive committee co-chair and professor at the German Heart Center of Charité University Medicine Berlin, added: “In this regard, the FROST-HF trial is the most comprehensive trial comparing inter-atrial shunting to the latest guideline directed therapies across the broad heart failure phenotype with potential to impact on advancing existing standard of care.”
Finally, Sabine Bois, CEO of Occlutech, stated: “Kicking off the FROST-HF study is an important milestone for Occlutech. It takes us one step closer to becoming the global leader in the interventional heart failure market at the same time as we are focusing our development efforts on the large US market. The potential US market size for shunt devices designed for treatment of heart failure is significant, and with a continued focus on the US, we deem it as a future key market for our portfolio of market leading devices.”
Betsy Goodfellow
