AorticLab Gains Approval for FLOWer™ Clinical Investigation
AorticLab has achieved a significant milestone as it has received FDA approval for its Investigational Device Exemption (IDE) to initiate a clinical investigation of the FLOWer™ System. This innovative device acts as a full-body embolic protection system designed specifically for use during complex transcatheter intracardiac procedures.
With its CE mark obtained earlier under MDR regulations, the FLOWer System has demonstrated success in various extraordinarily intricate procedures across multiple countries in Europe. The FDA approval now allows the company to expand its clinical investigations to leading centers in the United States, with renowned facilities such as Montefiore Medical Center participating in the studies.
CEO of AorticLab, Franco Osta, expressed enthusiasm regarding this recent development, stating that it represents a crucial step towards providing U.S. patients access to safer and more effective devices aimed at improving the outcomes of structural heart interventions.
Enrico Pasquino, the Chief Scientific Officer at AorticLab, highlighted the design intent behind the FLOWer System, stating that it incorporates elements tailored to TAVI procedural integration and prioritizes patient safety. The pivotal trial will gather essential data to address the growing need for comprehensive embolic protection, particularly for patients at a heightened risk of experiencing strokes during cardiology procedures.
Leading the clinical investigation is Dr. Azeem Latib, the Section Head of Interventional Cardiology at Montefiore Medical Center. Dr. Latib remarked on the potential of the FLOWer System to offer a patient-centric approach that significantly mitigates stroke risks during TAVI procedures. He expressed excitement about overseeing this groundbreaking trial.
It is important to note that the FLOWer System is currently classified as an investigational medical device undergoing clinical evaluation. As such, it is not yet available in the United States market. However, its recognition through CE marking in early 2024 confirms its compliance with European regulatory standards.
Understanding the FLOWer™ System
The FLOWer™ System is strategically designed with the purpose of delivering exceptional embolic protection during intracardiac procedures. This temporary, transcatheter-based filter excels in its functionality, showcasing an innovative quick deployment and retrieval mechanism. With a filter porosity of 60 µm, it optimally enhances the safety and effectiveness of TAVI procedures.
About AorticLab
AorticLab stands as a privately held medical technology company dedicated to advancing solutions within interventional cardiology. The company’s mission centers on augmenting procedural safety and improving patient outcomes. They prioritize pioneering technologies that integrate effectively into existing clinical workflows, ensuring that innovative solutions contribute positively to patient care.
Moving Forward with Innovation
The approval of the FLOWer IDE by the FDA marks a pivotal moment in AorticLab's journey. As the company embarks on this new chapter, it aims to further its commitment to the development of advanced medical devices that can significantly enhance the quality of care for patients requiring intricate cardiac interventions.
Frequently Asked Questions
What is the FLOWer™ System?
The FLOWer™ System is a temporary transcatheter-based filter designed for full embolic protection during intracardiac procedures.
Which regulatory body approved the FLOWer™ clinical investigation?
The U.S. Food and Drug Administration (FDA) approved the FLOWer™ clinical investigation through an Investigational Device Exemption (IDE).
What are the expected benefits of the FLOWer™ System?
The system aims to enhance procedural safety and reduce the risk of stroke during TAVI procedures, offering better patient outcomes.
Where are the clinical trials for FLOWer™ being conducted?
The clinical trials will be conducted at leading medical centers in the United States, including Montefiore Medical Center.
Is the FLOWer™ System available for patients in the U.S.?
Currently, the FLOWer™ System is an investigational device and is not available in the United States market.
