The ProtEmbo cerebral protection system (Protembis) has been used, to complement a transcatheter aortic valve implantation (TAVI) procedure, for the first time in a clinical setting. The safety and feasibility of the ProtEmbo—an intra-aortic filter device that is designed to deflect embolic material arising during TAVI away from the brain—are currently being assessed in an ongoing European trial.
According to a press release, the ProtEmbo system was successfully deployed via the left radial artery across all three branches of the aortic arch for the duration of the TAVI procedures. The procedures were conducted under conscious sedation. On completion of the valve implant, the system was safely withdrawn without difficulty. None of the patients experienced a stroke event and there were no other device-related adverse events.
Darren Mylotte (Galway University Hospital, Galway, Ireland) and colleagues performed the first-in-human procedure with the ProtEmbo System. Mylotte comments: “With TAVI shifting to younger and lower-risk patients, cerebral protection becomes even more important. Clinical data from two recent studies of intermediate-risk patients undergoing TAVI suggest 30-day stroke risk as high as 5.5%. It is, therefore, critically important that we have a cerebral-focused protection device that will reduce the frequency of embolic events. The ProtEmbo system shows tremendous promise in reaching this clinical objective—first-in-human use of the device was safe and feasible.”
The press release reports that Protembis has developed the ProtEmbo cerebral protection system to not only minimise the risk of cerebrovascular events related to TAVI but to also minimise the risk of such events related to many other interventional and surgical procedures. It adds that features and benefits of the ProtEmbo include:
- Low-profile access via left radial artery (6Fr guiding sheath)
- Best access route: no interference with TAVR catheter or accessories
- Simple, quick, and reliable deployment
- Complete coverage of all three aortic side branches
- Deflection of micro particles, as tiny as 6o microns
- Suitable for a wide variety of aortic arch anatomies
- Heparin coating for optimal biocompatibility.