TORINO, Italy – October 2, 2025 – AorticLab has achieved a major milestone with the U.S. Food and Drug Administration (FDA) granting Investigational Device Exemption (IDE) approval for the FLOWer™ System pivotal clinical investigation. The FLOWer System, a full-body embolic protection device designed for transcatheter intracardiac procedures such as transcatheter aortic valve implantation (TAVI), is poised to redefine patient safety standards in interventional cardiology. Following CE mark approval in early 2024, the device has already demonstrated promising outcomes in complex cardiovascular procedures across several European Union countries. With the IDE approval, AorticLab can now initiate a pivotal trial in the United States at leading centers, including Montefiore Medical Center in New York.
Science Significance
The FLOWer™ System is a transcatheter-based filter engineered for complete embolic protection during intracardiac procedures. Unlike current partial protection devices, FLOWer offers full-body coverage with an innovative 60 µm filter mesh, designed to capture debris that may otherwise cause embolic events such as strokes, kidney injury, or peripheral ischemia. Its quick deployment and retrieval mechanism ensures procedural efficiency and integration into TAVI workflows without compromising clinical outcomes. By addressing a critical unmet need for comprehensive embolic protection, the FLOWer device exemplifies the next generation of cardiovascular safety innovations. The upcoming U.S. pivotal trial will provide the robust evidence necessary to validate its safety and efficacy across diverse patient populations.
Regulatory Significance
The FDA’s IDE approval signifies regulatory confidence in FLOWer’s clinical potential and design integrity. This step allows AorticLab to conduct pivotal trials aimed at securing a future Premarket Approval (PMA) for commercialization in the U.S. The IDE complements FLOWer’s existing CE certification under the European Medical Device Regulation (MDR), reflecting compliance with stringent international standards.FDA Breakthrough-level authorizations for devices like FLOWer underline global momentum toward safer, patient-centered cardiovascular technologies. If successful, the pivotal trial will accelerate access for U.S. patients and set a benchmark for embolic protection device evaluations in regulatory science.
Business Significance
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For AorticLab, the IDE approval marks a turning point in its growth trajectory. The company has positioned itself as a leader in MedTech innovation for interventional cardiology, with FLOWer as its flagship product. Beyond FLOWer, AorticLab’s research pipeline includes technologies targeting valve debridement and advanced embolic filtering solutions, broadening its future market potential.The U.S. embolic protection device market is projected to grow significantly, driven by increasing adoption of TAVI and other minimally invasive cardiac procedures. By entering pivotal trials, AorticLab not only validates its science but also enhances its attractiveness to global investors and strategic partners. This move underscores the company’s commitment to combining engineering excellence, regulatory rigor, and commercial readiness to achieve long-term competitiveness.
Patients’ Significance
Stroke remains one of the most feared complications of TAVI, with rates ranging from 3% to 5% in major studies. FLOWer directly addresses this challenge by offering full-body embolic protection, designed to reduce peri-procedural stroke and other embolic complications.For patients at high risk—elderly individuals, those with calcified aortic valves, or those with comorbidities—the FLOWer System provides a new layer of safety and reassurance during life-saving cardiac interventions. Its integration into existing workflows ensures minimal disruption for clinicians while potentially transforming patient outcomes.The U.S. pivotal trial at Montefiore Medical Center will generate vital data on procedural safety, efficacy, and clinical endpoints, giving patients and physicians confidence in adopting this innovative technology.
Policy Significance
The approval highlights broader policy momentum toward fostering innovation in rare and high-risk cardiovascular diseases. Regulators in both the EU and U.S. are emphasizing accelerated pathways for devices that address urgent unmet medical needs such as embolic protection during TAVI.AorticLab’s progress reinforces the value of collaborative regulatory frameworks that prioritize patient safety while enabling timely access to innovation. The pivotal FLOWer investigation will also serve as a test case for how emerging MedTech firms can navigate international regulatory harmonization, ultimately benefiting patients worldwide.
Transaction Highlights
AorticLab’s FDA IDE approval for the FLOWer™ System represents a pivotal moment in the company’s regulatory and clinical strategy. Building on its CE MDR certification gained in Q1 2024, the device has already been successfully deployed in several complex procedures across Europe, providing early validation of its safety and effectiveness. With the green light to begin pivotal trials in the United States, AorticLab is strategically positioned to expand its clinical footprint and generate the robust data required for a future Premarket Approval (PMA) submission. The trial will take place at leading U.S. cardiac centers such as Montefiore Medical Center in New York, under the direction of Dr. Azeem Latib, a recognized leader in interventional cardiology. These studies are designed to evaluate FLOWer’s ability to deliver full-body embolic protection, reduce the risk of peri-procedural stroke, and ensure procedural efficiency in TAVI and other intracardiac interventions. By combining European clinical experience, FDA IDE authorization, and a clear pathway toward commercialization, AorticLab is reinforcing its position as an emerging global player in MedTech innovation and advancing its mission to deliver safer, more effective cardiovascular care.
Source: AorticLab Press Release
