Minimally invasive cardiac devices provider Occlutech has enrolled the first participant in the FROST-HF study of its Atrial Flow Regulator (AFR).
The multi-centre, double-blinded, randomised, sham-controlled FROST-HF study has been designed to evaluate the effectiveness and safety of the AFR to treat heart failure patients with either preserved ejection fraction (HFpEF) or reduced ejection fraction (HFrEF).
A total of 588 participants in Europe, Canada and the US are planned to be randomised for the Investigational Device Exemption trial, along with an additional roll-in cohort of 110 patients.
The data from the trial will help the company apply to the US Food and Drug Administration (FDA) for a marketing application for commercial use of the AFR in the country.
The AFR is a small device that can be used to keep a shunt between the two upper chambers of the heart open, as well as control its size.
It comprises two disks with a central opening (fenestration or shunt), which enable blood to flow through the AFR from the left to the right side of the heart.
The device is implanted using established and safe minimally invasive (transcatheter) methods that are performed by an interventional cardiologist.
Occlutech CEO Sabine Bois said: “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.”