EnCompass receives FDA conditional IDE approval to commence a US pilot study of its F2 cerebral embolic protection (CEP) system in patients undergoing transcatheter aortic valve replacement (TAVR)
All cardiovascular procedures cause the release of particulate debris (calcium, vessel wall, blood clot) and air bubbles, called emboli.
- All cardiovascular procedures cause the release of particulate debris (calcium, vessel wall, blood clot) and air bubbles, called emboli.
- During the TAVR procedure, 360-degree wall apposition of the F2 filter in the aortic arch is designed to prevent migration.
- Because the F2 filter is attached to a self-expanding nitinol stent, it is easy to insert, deploy, and retrieve.
- In September 2023, a similar pilot study began in Australia and now with FDA conditional IDE approval, EnCompass plans to commence its first US pilot study.