Occlutech has announced the completion of patient enrolment in its pilot study to assess safety and efficacy of the novel atrial flow regulator (AFR) in heart failure (HF) patients—the PRELIEVE trial.
PRELIEVE is a prospective, multicentre, open-label, non-randomised pilot study that evaluates the results of AFR implantation in patients with either heart failure with preserved ejection fraction (HFpEF) or heart failure with reduced ejection fraction (HFrEF).
AFR is a minimally invasive cardiac implant that is designed to maintain a permanent interatrial communication and allows controlled blood flow from overloaded left atrium to the lower pressure right atrium.
“The completion of the enrolment is another important milestone for Occlutech and we are excited to support this therapy option for heart failure patients with our clinical activities,” said Sabine Bois, CEO Occlutech Group.
Occlutech has sales of congenital and structural heart products in over 80 countries and maintains manufacturing and R&D facilities in Jena, Germany and Istanbul, Turkey.
The AFR is not approved in the USA. Product availability is subject to local regulatory clearance. The AFR is under clinical investigation for use in patients with pulmonary arterial hypertension and use in these patients is limited by applicable national laws.