EnCompass F2 Cerebral Embolic Protection System Receives Conditional IDE Approval for Pilot Study

September 27, 2023—EnCompass Technologies, Inc. announced that the FDA granted conditional investigational device exemption approval for its F2 cerebral embolic protection system. The company now plans to commence its first United States pilot study in 2024.

According to the company, the EnCompass F2 filter features pores small enough (30 µm) to block most emboli to the brain while preserving blood flow. During transcatheter aortic valve replacement (TAVR) procedures, 360º wall apposition of the F2 filter in the aortic arch is designed to prevent migration. It is attached to a self-expanding nitinol stent, so it is easy to insert, deploy, and retrieve.

The company reported that investigators from UCLA in Los Angeles, California, presented an in vitro study comparing the filter versus the Sentinel cerebral embolic protection system (Boston Scientific Corporation) at SNIS 2023, the Society of NeuroInterventional Surgery’s 20th annual meeting held July 31 to August 4 in San Diego, California.

In the study, which used a three-dimensional printed silicone model of the aortic arch perfused with saline at 5 L-min^-1, artificial emboli of three sizes (45-53 µm, 106-125 µm, and 250-300 µm) were injected into the aortic root. Effluent was continuously collected from the left and right common carotid and vertebral arteries. For all sizes of emboli, the F2 filter prevented 94% more emboli from reaching the brain than Sentinel.

In June 2023, the company announced the first-in-human study of the F2 cerebral embolic filter; the device was used in three TAVR procedures at the Israeli-Georgian Medical Research Clinic in Tbilisi, Georgia. The study’s small cohort of patients demonstrated 100% procedural success and no adverse events. In September 2023, a similar pilot study began in Australia.

F2 is not commercially available and is intended for investigational use only, advised EnCompass.