Tag: Occlutech

Occlutech granted important conditional FDA approval for PFO Study (OCCLUFLEX) in the U.S.

SCHAFFHAUSEN, Switzerland, Aug. 16, 2021 /PRNewswire/ — Occlutech Holding AG (“Occlutech”), one of the world´s leading providers of minimally invasive structural heart disease devices, announces the conditional U.S. Food and Drug Administration (“FDA”) approval of its Investigational Device Exemption (“IDE”) application to conduct a […]

Occlutech announces Completion of Patient Enrolment in Pilot Study of Atrial Flow Regulator (AFR) in Patients with Heart Failure

SCHAFFHAUSEN, Switzerland, Feb. 24, 2021 /PRNewswire/ — Occlutech, a privately-held company, announced today 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 (PRELIEVE trial). PRELIEVE is […]

Occlutech’s Atrial Flow Regulator (AFR) Receives U.S. FDA Breakthrough Device Designation

SCHAFFHAUSEN, Switzerland, Dec. 18, 2020 /PRNewswire/ — Occlutech, a privately-held company, announced today that the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its first-in-class, implantable Atrial Flow Regulator (AFR) for Pulmonary Arterial Hypertension (PAH). PAH […]