AorticLab has announced CE mark certification for the FLOWer transcatether embolic protection device (EPD) indicated for the cerebral and systemic protection of patients undergoing transcatheter aortic valve implantation (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 commercialisation of the device throughout Europe, the company said in a press release.
FLOWer is equipped with Catch&Flow technology, and captures emboli up to 60μm in size, protecting the brain and peripheral organs from ischaemic events during TAVI procedures.
Filippo Scalise (Policlinico di Monza, Monza, Italy), principal investigator of the Nautilus clinical study, comments: “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, says: “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, states: “We are ready for the commercialisation 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, adds: “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 USA to obtain FDA certification.”
