TORINO, Italy — October 2, 2025 — Leads & Copy — AorticLab announced 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, an innovative full-body embolic protection device, is designed for use during transcatheter intracardiac procedures.
Having obtained the CE mark under MDR in Q1 2024, FLOWer has been utilized in complex procedures in several EU countries. The IDE approval facilitates a clinical investigation at leading USA Centers, including Montefiore Medical Center in New York, to evaluate procedural safety, device efficacy, and early clinical outcomes.
According to Franco Osta, CEO of AorticLab, FDA approval of the FLOWer IDE is a milestone, aiming to provide US patients with a safe and effective device to improve structural heart intervention outcomes. Enrico Pasquino, Chief Scientific Officer, added that the FLOWer System was designed with TAVI procedural integration, full embolic protection and patient safety in mind.
Dr. Azeem Latib, Section Head of Interventional Cardiology of Montefiore Medical Center in New York and Principal Investigator of the clinical investigation, stated that the FLOWer System offers a promising new patient tailored approach in reducing the risk for stroke occurrence during TAVI procedures.
FLOWer is a temporary transcatheter-based filter designed for full embolic protection during intracardiac procedures. It features an innovative quick deployment and retrieval mechanism, a full body embolic protection thanks to its design, best in class filter porosity of 60 µm. FLOWer is optimized to allow a safe and effective TAVI procedure. FLOWer is an investigational medical device currently undergoing clinical evaluation under the FDA-approved IDE and is not available in USA. FLOWer is a CE marked device since early 2024 .
Contact: Federica D’Ortona, federica.dortona@aorticlab.ch, +39 3203389475
Source: AorticLab
