FDA grants IDE to EnCompass for cerebral embolic protection system in TAVR procedures

The F2 device. [Image from the EnCompass Technologies website]EnCompass Technologies announced today that it received FDA investigational device exemption for its F2 cerebral embolic protection system.

The conditional IDE enables a study of the F2 system for protecting patients from brain injury during cardiovascular procedures.

According to a news release, all cardiovascular procedures cause the release of particulate debris and air bubbles — emboli. Emboli can cause injury if they reach the brain. This can occur in procedures like transcatheter aortic valve replacement (TAVR), an ever-growing cardiovascular procedure.

EnCompass’ F2 filter has pores small enough to block most emboli to the brain while preserving blood flow. During the TAVR procedure, 360-degree wall apposition of the filter in the aortic arch prevents migration. The filter, attached to a self-expanding, nitinol stent, is easy to insert, deploy and retrieve.

Earlier this year, …

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