AorticLab has announced that the US Food and Drug Administration (FDA) has approved its investigational device exemption (IDE) for the FLOWer system pivotal clinical investigation.
The FLOWer system is a full-body embolic protection device designed for use during transcatheter intracardiac procedures such as transcatheter aortic valve implantation (TAVI). Since obtainment of the CE mark in Q1 2024, FLOWer has been successfully utilised in very complex procedures, in several EU countries, AorticLab said in a press release.
The IDE approval allows the commencement of a clinical investigation at US centres 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 US patients a safe and effective device to improve outcome of structural heart interventions,” said Franco Osta, chief executive officer 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.”
Azeem Latib, section head of interventional cardiology of Montefiore Medical Center 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, following approval in early 2024.
