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

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 Occlutech’s Flex II PFO Occluder to the…

thaipr.net

17 ส.ค. 64

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 Occlutech Holding AG (“Occlutech”) today announces that Marianne Dicander Alexandersson, Mette-Marie Harild, Helena Levander, and Michel Lussier have been elected as members of the Board of […]

thaipr.net

5 พ.ค. 64

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

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 results of AFR implantation in patients with either heart […]

thaipr.net

25 ก.พ. 64

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

Occlutech, a privately-held company, announced today that the U.S Food and Drug Administration (FDA) has granted the Company a Breakthrough Device designation for its first-in-class, implantable Atrial Flow Regulator (AFR) for heart failure (HF) patients with preserved (HFpEF) or reduced (HFrEF) ejection fraction. Heart failure (HF) is a serious condition characterized by the heart’s inability […]

thaipr.net

20 ม.ค. 64

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

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 is resulting from changes in cells that causes damages […]

thaipr.net

21 ธ.ค. 63