AorticLab Receives IDE Approval for Pivotal Trial of FLOWer Embolic Protection Device

October 2, 2025—AorticLab announced that the FDA has approved an investigational device exemption (IDE) for the pivotal clinical trial of the company’s FLOWer system. FLOWer is a full-body embolic protection device designed for use during transcatheter intracardiac procedures, including transcatheter aortic valve replacement (TAVR).

The company advised that the IDE approval allows the commencement of the clinical trial at leading centers in the United States to evaluate procedural safety, device efficacy, and early clinical outcomes.

The Principal Investigator of the study is Azeem Latib, MD, Section Head of Interventional Cardiology of Montefiore Medical Center in New York, New York.

“The FLOWer system offers a promising new patient-tailored approach in reducing the risk for stroke occurrence during TAVR procedures,” commented Dr. Latib in the company’s press release. “I am excited to lead this pivotal trial.”

In early 2024, the company announced the FLOWer system was granted CE Mark approval under the European Union Medical Device Regulation. Since then, FLOWer has been successfully utilized in very complex procedures in several countries in the European Union, noted AorticLab.