09 Feb FLOWer™ is CE Marked
AorticLab™ is pleased to announce the successful achievement of CE certification for 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 future 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.
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.
CONTACTS:
info@aorticlab.ch
www.aorticlab.ch
Stefano Osta +39 3462489393 – stefano.osta@aorticlab.ch
Federica D’Ortona federica.dortona@aorticlab.ch
AorticLab™ is a company based in the BioindustryPark of Colleretto Giacosa (TO), focused on innovation and improvement in the treatment of aortic valve stenosis.
AorticLab™ collaborates with expert cardiologists and renowned research centers to identify and implement new technologies in the field of cardiology.
The AorticLab™ team consists of 25 people. The company promotes gender equality and inclusion and diversity, which are essential for enhancing creativity and productivity.
CARLO VANOLI: Having held top positions at various Medtech companies during over 30 years of experience in the industry, he is the Co-Founder and President of Medeor Associates and has been an investor in AorticLab™ since the first financing phase.
FRANCO OSTA: Co-Founder and CEO of AorticLab™, he has over thirty years of experience in the medical device industry, holding positions such as Controller and CFO in multinational companies such as Sorin Group and CID, which he co-founded through a management buyout.
ENRICO PASQUINO: Co-Founder and CSO of AorticLab™, he has over 35 years of experience in preclinical activities (R&D, Regulatory, and Clinical Affairs) for cardiovascular devices, serving as Vice-President of Clinical Affairs for companies such as Sorin Group and Edwards LS.