#USA #New York #FDA Approval #AorticLab #FLOWer

AorticLab's Revolutionary FLOWer™ System Gains FDA Approval

AorticLab, an innovative player in the field of interventional cardiology, has recently reached a significant milestone in its quest to enhance patient care. The company announced that it has received the U.S. Food and Drug Administration's (FDA) approval for its Investigational Device Exemption (IDE) related to its advanced medical device, the FLOWer™ System. This approval allows AorticLab to initiate a pivotal clinical investigation of the FLOWer device at prominent medical centers in the United States, including the esteemed Montefiore Medical Center in New York.

What is the FLOWer™ System?

The FLOWer™ System is a state-of-the-art, full-body embolic protection device designed for use during transcatheter intracardiac procedures. Aimed particularly at improving the safety and effectiveness of these intricate procedures, the FLOWer device features an innovative design that ensures full embolic protection for patients. The device boasts a quick deployment and retrieval mechanism, with a filter porosity of 60 µm, optimized for safe transcatheter aortic valve implantation (TAVI).

AorticLab's commitment to improving procedural safety and patient outcomes is evident in the design of the FLOWer System, which integrates seamlessly into existing clinical workflows. The company has already seen success with the device across various complex procedures in European Union countries since obtaining CE mark approval in early 2024 under the Medical Device Regulation (MDR).

Clinical Investigation Details

With the IDE approval in hand, AorticLab is set to begin its clinical investigation, focusing on assessing the procedural safety, device efficacy, and early clinical outcomes associated with the FLOWer System. The study aims to provide crucial evidence that addresses the significant unmet need for comprehensive embolic protection for patients undergoing interventional cardiology procedures.

Franco Osta, the CEO of AorticLab, remarked, “The FDA approval of the FLOWer IDE marks a major milestone for AorticLab, as we strive to offer U.S. patients a safe and effective tool to improve outcomes in structural heart interventions.” As excitement builds around the FLOWer System, Dr. Azeem Latib, who will lead the clinical investigation at Montefiore Medical Center, stated, “The FLOWer System offers a promising new patient-tailored approach to reducing the risk of stroke during TAVI procedures.”

The FLOWer System, however, is still under clinical evaluation, and it is important to note that it is not yet available for use in the United States until the completion of this investigation.

The Future of Cardiac Care

AorticLab’s progress with the FLOWer™ System exemplifies the ongoing innovation in medical devices aimed at enhancing patient safety and improving outcomes in cardiology. The need for effective embolic protection becomes critical during complex procedures, especially for patients at elevated risk of stroke. As the clinical investigation unfolds at leading medical centers, the results will provide valuable insights that could reshape the landscape of interventional cardiology.

In conclusion, AorticLab is on the cutting edge of cardiology technology with its FLOWer™ System, promising to revolutionize how procedures are conducted and ultimately enhance the safety and efficacy of patient care within the field.

About AorticLab

AorticLab is a privately held medical device company dedicated to delivering advanced solutions in interventional cardiology. Focused on fostering innovation and enhancing patient outcomes, AorticLab continues to develop technologies that prioritize patient safety and procedural efficiency.