ThaiPR.NET https://www.thaipr.net/location/schaffhausen-switzerland Press Release Distribution Center of Thailand Tue, 21 Apr 2026 17:30:51 +0700 hourly 1 https://wordpress.org/?v=6.1.1 <![CDATA[Occlutech granted important conditional FDA approval for PFO Study (OCCLUFLEX) in the U.S.]]> https://www.thaipr.net/en/health_en/3086936 Tue, 17 Aug 2021 08:15:31 +0700 health_en https://www.thaipr.net/en/health_en/3086936 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 standard […]

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]]> <![CDATA[Occlutech takes important step towards approval in China]]> https://www.thaipr.net/en/health_en/3060910 Wed, 02 Jun 2021 12:50:11 +0700 health_en https://www.thaipr.net/en/health_en/3060910 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 completion of the patient recruitment represents […]

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]]> <![CDATA[New members elected to Occlutech Board of Directors]]> https://www.thaipr.net/en/health_en/3051117 Wed, 05 May 2021 11:00:07 +0700 health_en https://www.thaipr.net/en/health_en/3051117 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 […]

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]]> <![CDATA[Occlutech announces Completion of Patient Enrolment in Pilot Study of Atrial Flow Regulator (AFR) in Patients with Heart Failure]]> https://www.thaipr.net/en/health_en/3033000 Thu, 25 Feb 2021 17:35:07 +0700 health_en https://www.thaipr.net/en/health_en/3033000 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 […]

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]]> <![CDATA[Occlutech’s Atrial Flow Regulator (AFR) Receives U.S. FDA Breakthrough Device Designation for Heart Failure (HF)]]> https://www.thaipr.net/en/health_en/3020544 Wed, 20 Jan 2021 13:00:00 +0700 health_en https://www.thaipr.net/en/health_en/3020544 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 […]

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]]> <![CDATA[Occlutech’s Atrial Flow Regulator (AFR) Receives U.S. FDA Breakthrough Device Designation]]> https://www.thaipr.net/en/health_en/3012049 Mon, 21 Dec 2020 13:22:17 +0700 health_en https://www.thaipr.net/en/health_en/3012049 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 […]

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