AorticLab Gets FDA IDE Approval for FLOWer Clinical Pivotal Investigation

Oct. 2, 2025 — AorticLab recently announced 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 during transcatheter intracardiac procedures. Since obtainment of the CE mark under MDR in Q1 2024, FLOWer has been successfully utilized in very complex procedures, in several EU countries.

The IDE approval allows to begin a clinical investigation at leading USA Centers, including Montefiore Medical Center in New York, with the study evaluating procedural safety, device efficacy, and early clinical outcomes.

"FDA approval of the FLOWer IDE marks a major milestone for AorticLab , with the aim of providing also to the US patients a safe and effective device to improve outcome of structural heart interventions" said Franco Osta, CEO of AorticLab.

Enrico Pasquino, Chief Scientific Officer of AorticLab, added: "The FLOWer System was designed with TAVI procedural integration, full embolic protection and patient safety in mind. This US pivotal clinical investigation will provide critical evidence to address the unmet need for total embolic protection, especially in patients at higher risk of stroke during cardiology interventions."

Dr. Azeem Latib, Section Head of Interventional Cardiology of Montefiore Medical Centerin New York and Principal Investigator of the clinical investigation, commented: "The FLOWer System offers a promising new patient tailored approach in reducing the risk for stroke occurrence during TAVI procedures. I am excited to lead this pivotal trial."

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 .

Additional information is available at www.aorticlab.ch.