News - AorticLab

23 Jun Assessment of the Safety and Effectiveness of the FLOWer Antiembolic Filter Supporting Transcatheter Aortic Valve Implantation

Posted at 11:19h in News by Aorticlab

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Abstracthttps://pubmed.ncbi.nlm.nih.gov/41709490/Background: Embolic events are life-threatening complications of transcatheter aortic valve implantation (TAVI) with clinically relevant stroke rates of 2%-4%.Aims: This study aims to evaluate the safety and effectiveness of FLOWer, a novel embolic protection device (EPD) used in TAVI procedures.Methods: Data on the FLOWer device were obtained from...

23 Jun AorticLab Receives FDA Approval to Initiate FLOWer™ Clinical Pivotal Investigation

Posted at 11:13h in News by Aorticlab

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TORINO, Italy, Oct. 2, 2025 /PRNewswire/ -- AorticLab announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) for the FLOWer™ System pivotal clinical investigation. The FLOWer System is an innovative full-body embolic protection device designed for use...

20 Jan AorticLab S.r.l. Announces Clear Victory Before the European Unified Patent Court in Litigation Brought by Emboline, Inc.

Posted at 16:15h in News by Aorticlab

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AorticLab's FLOWer™ embolic protection device has received full clearance following the Unified Patent Court's clear dismissal of Emboline's infringement claims regarding European Patent EP 2129425, ensuring continued patient access to its innovative technology COLLERETTO GIACOSA, Italy, Jan. 20, 2026 /PRNewswire/ -- AorticLab S.r.l. today announce sits clear victory before the Court...

09 Feb FLOWer™ is CE Marked

Posted at 12:01h in News by Aorticlab

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AorticLab™ is pleased to announce the successful achievement of CE certification for FLOWer™, an innovative transcatether embolic protection device (EPD) indicated for the cerebral and systemic protection of patients undergoing transcatheter aortic valve replacement (TAVI) procedures. The CE certification of FLOWer, a Class III medical...

23 Jul AorticLab has obtained ISO13485 certification for the design and development of its products

Posted at 15:09h in News by Aorticlab

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AorticLab has obtained ISO13485 certification for the design and development of its products. It certifies that Aorticlab has established and is maintaining a quality management system, which meets the requirements of the standard. We are proud: it means we've made a good job, as a great...

26 May AorticLab announces First in Human cases of FLOWer, the unique embolic protection device

Posted at 10:28h in News by Aorticlab

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AorticLab, a leading innovator of cutting-edge technology solutions to treat aortic stenosis and improve patients’ safety, based in Colleretto Giacosa Bioindustry Park – Turin Italy, - today announced the positive completion of the first three human procedures of its FLOWer embolic protection filter. The first...

18 May EuroPCR – Congress of the European Association of Percutaneous Cardiovascular Interventions

Posted at 10:22h in News by Aorticlab

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Presentation for innovation EMBRACE Transcatheter antiembolic filter Dr F. Scalise www.pcronline.com...

17 Apr CRT Meeting – Interventional Cardiology Conference

Posted at 10:20h in News by Aorticlab

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Embrace Transcatheter Antiembolic Filter Presentation for “Best innovation Competition” Dr. Filippo Scalise Innovation Award...

03 Feb Trans-Catheter Double-Frequency Ultrasound Ablator for The Treatment of Aortic Valve Leaflets Calcification

Posted at 09:41h in clinical, News by Aorticlab

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Degenerative aortic stenosis (AS) is the most common heart valve disease in developed countries. The prevalence of AS increases with age and varies from 0.2% at ages 50 to 59 years to 1.3% at 60 to 69 years, 3.9% at 70 to 79 years, and...

06 Dec ICI – Innovations in Cardiovascular Interventions Meeting

Posted at 10:07h in News by Aorticlab

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Innovation Poster https://icimed.org/...