AorticLab received FDA approval for an Investigational Device Exemption (IDE) to begin a pivotal clinical trial of its FLOWer System in the U.S.
The FLOWer System is a transcatheter embolic protection device designed for use during intracardiac procedures, including transcatheter aortic valve implantation (TAVI). It obtained CE mark certification under the EU Medical Device Regulation in early 2024 and has since been used in complex procedures in several European countries.
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The U.S. pivotal trial will launch at sites including Montefiore Medical Center in New York. Investigators will evaluate 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 AorticLab CEO Franco Osta.
AorticLab designed the FLOWer System to integrate with TAVI procedures and provide full embolic protection.
“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,” Chief Medical Officer Enrico Pasquino.
The FLOWer System remains investigational in the U.S. and is not commercially available. It has been CE marked in Europe since 2024.
“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,” Dr. Azeem Latib, section head of interventional cardiology at Montefiore and principal investigator of the trial, said.
