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 pivotal study, OCCLUFLEX, comparing Patent Foramen Ovale (“PFO”) closure by […]
Tag: Occlutech
Occlutech takes important step towards approval in China
SCHAFFHAUSEN, Switzerland, June 1, 2021 /PRNewswire/ — Occlutech AG (“Occlutech” or the “Company”) today announces that the planned recruitment of 180 patients has been reached in the Company’s trial in China for its ASD Occluder. The Occlutech ASD Occluder is used in the treatment of Atrial Septal Defects (ASD), which is a congenital heart condition. The […]
New members elected to Occlutech Board of Directors
Medical device company Occlutech Holding AG, one of the world´s leading providers of minimally invasive structural heart disease devices, announces the election of four new members to the board SCHAFFHAUSEN, Switzerland, May 3, 2021 /PRNewswire/ — Occlutech Holding AG (“Occlutech”) today announces that Marianne Dicander Alexandersson, Mette-Marie Harild, Helena Levander, and Michel Lussier have been elected as […]
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 a prospective, multicenter, open-label, non-randomized pilot study that evaluates the […]
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 affects hundreds of thousands in the U.S. and globally and […]
Occlutech AFR Heart Failure Device Obtains CE Mark Approval
SCHAFFHAUSEN, Switzerland, Sept. 6, 2019 /PRNewswire/ — Occlutech AG announced today that its atrial flow regulator, the Occlutech AFR device, has obtained CE mark approval clearing it for sales on the European CE regulated market. Occlutech AFR is a next generation intra-atrial shunt device, intended to treat heart failure symptoms by decompressing abnormal […]
Occlutech Obtains European CE Mark for its Novel PmVSD Occluder
NEWS PROVIDED BY – Occlutech – 05 Apr, 2017, 07:00 ET SCHAFFHAUSEN, Switzerland, April 5, 2017 /PRNewswire/ — Occlutech, a leading innovator of implants to treat structural heart disease, today announced that it has obtained European CE Mark approval for its Perimembranous Ventricular Septal Defect (PmVSD) Occluder. The device is a […]