AorticLab™ is pleased to announce the successful achievement of CE certification for FLOWer™ (FLOWer), an innovative transcatether embolic protection device (EPD) indicated for the cerebral and systemic protection of patients undergoing transcatheter aortic valve replacement (TAVI) procedures. The CE certification of FLOWer, a Class III medical device obtained in full compliance with the Medical Device Regulation (MDR), will allow for the production and commercialization of the device throughout the European territory.
This important milestone brings AorticLab™ closer to its mission of improving the treatment of aortic valve stenosis by offering patients safer and more effective procedures. The transcatether device FLOWer™, equipped with Catch&Flow™ technology, captures emboli up to 60µm in size, protecting the brain and peripheral organs from ischemic events during TAVI procedures.
Filippo Scalise, Director of the Department of Interventional Cardiology at the Policlinico of Monza and Principal Investigator of the "Nautilus" Clinical Study, presents the device: "FLOWer will be part of the new frontier of cardiovascular medical devices; EPDs can make a difference for our patients, providing a higher and more comprehensive level of protection against embolic events during TAVI procedures. The FLOWer™ medical device offers an intuitive user interface that allows for rapid device positioning and stable anchoring in the aortic arch during the procedure."
Carlo Vanoli, Chairman of AorticLab™, emphasizes the importance of this achievement, stating: "Obtaining CE certification for FLOWer™ represents a significant turning point for AorticLab™, demonstrating our commitment to transforming innovative ideas into concrete solutions. We express our gratitude to the AorticLab™ Research team for their extraordinary dedication. This is just the first of many positive results we expect from this company."
CEO and Co-Founder Franco Osta looks to the future, stating: "We are ready for the commercialization phase of the device. Thanks to our collaboration with regional and national medical device distribution companies, we will be able to reach the best European Cardiology Centers and collaborate with leading cardiologists in the innovation of the field. A heartfelt thank you to our Investors, Angels, Friends and Families, who have believed in us and supported us during these six years of our journey."
Enrico Pasquino, CSO and Co-Founder, presents prospects: "We will continue to invest in research and development of innovative minimally invasive medical solutions. The "Nautilus" Regulatory Clinical Study has provided excellent results in the use of FLOWer during TAVI procedures. This year, we will initiate a European Post-Market Clinical Study and evaluate the possibility of initiating a Clinical Study in the United States to obtain FDA certification.”
Claudio Zuccolotto, Champion of Italian Angels for Growth (IAG) in this investment, states: 'We enthusiastically celebrate the success of AorticLab™ in achieving the CE certification for FLOWer™. This milestone not only signifies progress in AorticLab's mission to enhance the treatment of aortic valve stenosis but also serves as an example of Italian excellence in the field of Biomedical Technologies. As IAG, we take pride in supporting this innovative initiative and look optimistically towards the future."
AorticLab™ expresses deep gratitude to all those who have facilitated and believed in the development of the project since its early stages. Without their support, achieving this important milestone would not have been possible. We look forward to this new phase of our journey with enthusiasm, always aware of offering patients effective protection and reducing the risk of cerebrovascular insults during cardiovascular interventional procedures.