One of the top manufacturers of minimally invasive structural heart disease devices, Occlutech Holding AG (Occlutech), has announced the enrollment of the first patient in the FROST-HF study. In the FROST-HF study, patients with heart failure with either preserved ejection fraction (HFpEF) or reduced ejection fraction (HFrEF) are being treated using Occlutech’s Atrial Flow Regulator (AFR) (HFrEF).
This trial, which is randomised, double-blinded, multi-center, and sham-controlled, enables Occlutech to gather information on the security and efficiency of the AFR device in patients. The information will help a marketing application for commercial usage in the US that will be submitted to the US Food & Drug Administration (FDA). In the US, Canada, and Europe, 588 patients and an extra roll-in cohort of 110 patients will be randomly assigned for the FROST-HF Investigational Device Exemption research.
The Occlutech AFR device is being used in this significant trial, which is currently enrolling its first patient to examine potential novel therapies for adults with heart failure. The first doctors to sign up for this ground-breaking trial were Drs. Miquel Alvarez Villela and Craig Basman from Northwell Health Lenox Hill Hospital. They paved the path for nearly 70 sites in the US and 70 centres in Europe, marking a crucial turning point for the investigation and Occlutech.
“Inter-atrial shunt devices hold out a significant hope for heart failure patients who continue to experience symptoms after taking medication. Lenox Hill Hospital is pleased to take part in this clinical trial and provide our patients with state-of-the-art equipment in the hope that it may help them treat this dangerous ailment. Dr. Miquel Alvarez, principal investigator at Lenox Hill Hospital, states, “We look forward to continuing our work for the progress of the discipline.
Heart failure affects at least 12 million people in the US and the EU. With its Atrial Flow Regulator therapy, Occlutech hopes to improve the lives of the several hundred thousand individuals who suffer from this debilitating ailment each year. For a rising number of individuals for whom there are few available treatments, the AFR has the potential to save lives and enhance quality of life. The market potential in the EU and the US is expected to be worth several billion euros and is expected to continue to expand.
“The FROST-HF study will provide a substantial contribution to our understanding of the benefits and risks of inter-atrial shunting in patients with heart failure who have both preserved and lowered left ventricular ejection fraction, according to the researchers. According to Prof. Dr. Gregg W. Stone, co-chair of the FROST-HF executive committee and professor at the Icahn School of Medicine at Mount Sinai Heart Health System in New York, “testing two different sizes of inter-atrial shunts in this study will provide unique insights and possibly signal how different magnitudes of inter-atrial shunting may contribute to the clinical benefit”.
Prof. Dr. Stefan Anker, FROST-HF executive committee co-chair and professor at the German Heart Center of Charité University Medicine Berlin, continues, “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. “The FROST-HF study’s launch marks a significant accomplishment for Occlutech. At the same time as we are concentrating our development efforts on the sizable US market, it moves us one step closer to becoming the world leader in the interventional heart failure market. “With a continuous focus on the US, we perceive it to be a future key market for our portfolio of market-leading devices because of the size of the prospective American market for shunt devices designed to treat heart failure,” says Sabine Bois, CEO of Occlutech.
When the heart is not pumping effectively enough to maintain a person’s health, heart failure occurs. Among other symptoms, patients with heart failure frequently feel shortness of breath, congestion, and swelling limbs. Systolic heart failure (HFrEF or systolic heart failure) and heart failure with preserved ejection fraction (HFpEF) are two types of left-sided heart failure (HFpEF or diastolic heart failure). Both are brought on by alterations in the walls of the heart’s ventricles, which result in them being either weak or rigid. As a result, the heart’s ability to pump blood is reduced.
No matter how hard the heart works, it will never be able to completely empty a ventricle of blood. The amount of blood that is pumped out of a filled ventricle with each heartbeat is known as the “ejection fraction” (EF). A shunt between the two upper chambers of the heart can be kept open and its size managed with the help of a tiny device called the atrial flow regulator (AFR). The AFR allows blood to flow from the left to the right side of the heart through two discs with a central opening (fenestration or shunt). Metal wires (nitinol) are braided and moulded into the final shape of the AFR to create the device. Medical devices made of nitinol have been safely implanted in hundreds of thousands of patients for many years. The AFR is implanted utilising recognised and secure minimally invasive (transcatheter) procedures carried out by trained medical professionals (interventional cardiologist).
The AFR and other interatrial shunting devices created in recent years can be safely implanted and relieve symptoms in HFpEF and HFrEF patients, according to several clinical investigations. The goal of Occlutech, a leading specialist in minimally invasive structural cardiac implants, is to raise the standard of living for those who have heart diseases.
