Occlutech Announces Completion of Patient Recruitment in Pivotal AFR Pilot Study for Heart Failure

SCHAFFHAUSEN, Switzerland, Feb. 25, 2021 /PRNewswire/ -- Occlutech, a private company, announced today that patient enrollment has been completed in its pilot study (the PRELIEVE trial) evaluating the safety and efficacy of its novel Atrial Flow Regulator (AFR) in patients with heart failure (HF).

PRELIEVE is a prospective, multicenter, open-label, non-randomized pilot study evaluating the efficacy of AFR implantation in patients with heart failure with preserved ejection fraction (HFpEF) or heart failure with reduced ejection fraction (HFrEF).

Heart failure affects millions of people worldwide, imposing a significant burden in terms of mortality and healthcare expenditures. Even with optimal medical therapy, many patients continue to experience persistent symptoms and reduced quality of life due to elevated left atrial pressure.

AFR is a minimally invasive cardiac implant designed to maintain permanent interatrial communication and regulate blood flow from the volume-overloaded left atrium to the right atrium, which has lower pressure.

“The completion of patient recruitment marks another significant milestone for Occlutech. We are pleased to support the availability of this treatment option for heart failure patients through our clinical trial efforts,” said Sabine Bois, CEO of the Occlutech Group.

Occlutech is one of the leading companies in this field, with its main products including PFO occluders and ASD occluders that utilize state-of-the-art technology. Occlutech sells products related to congenital and structural heart disease in more than 80 countries worldwide and has production and R&D facilities in Jena, Germany, and Istanbul, Turkey. Occlutech has developed many novel products and technologies to improve treatment for patients in these and related fields.

For more information about the company’s products, Occlutech AFR, or to inquire about participation in our patient registry, please visit the Occlutech website.www.occlutech.com, or throughAFR@occlutech.comContact us directly.

AFR has not yet been approved in the United States. Product availability is subject to local regulatory approval. The use of AFR in patients with pulmonary arterial hypertension is currently in the clinical research phase, and its use in patients is restricted by applicable national laws.