The Atrial Flow Regulator keeps a shunt between the two upper chambers of the heart open while also controlling its size. Credit: Artur Tumasjan / Unsplash.

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).

Go deeper with GlobalData

Go deeper with GlobalData

The gold standard of business intelligence.

Find out more

Discover B2B Marketing That Performs

Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.

Find out more

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.

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

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.”

Medical Device Network Excellence Awards - Nominations Closed

Nominations are now closed for the Medical Device Network Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact

Excellence in Action
HemoSonics has won the 2025 Marketing Award for its impactful promotion of theQuantra Hemostasis System and leadership in blood management education. See how targeted campaigns, thought leadership content, and hands on clinician training are accelerating Quantra’s market traction and shaping the future of hemostasis testing.

Discover the Impact