Excipio LV Prime Thrombectomy Device

The Excipio LV Prime Thrombectomy Device is a mechanical thrombectomy catheter indicated for the nonsurgical removal of emboli and thrombi from peripheral blood vessels. It consists of a nitinol braided basket component that opens and closes via an activation wire, designed to treat vessels 6-16 mm in diameter.

The device features a nitinol braided basket (16 mm fully expanded, 60 mm working length), ergonomic proximal handle, 150 cm working length, 0.035-inch guidewire compatibility, and 9.1 Fr minimum aspiration catheter diameter. It uses vacuum aspiration (-28 in Hg), is sterilized by ethylene oxide as a single-use device, and has a 2-year shelf life. The basket itself provides radiopacity without additional markers.

The device was evaluated per ISO 10993-1 for biocompatibility, which is the only consensus standard explicitly cited in the summary.

The Excipio LV Prime has the identical intended use and operates on the same mechanical principle as its predicate (Excipio LV, K223897) and reference device (Excipio SV, K221204). Although vessel diameter range differs (6-16 mm vs. 10-25 mm for predicate), the materials, design architecture, sterilization method, operating principles, and biocompatibility profile are the same or similar. All nonclinical bench tests met acceptance criteria with performance similar to predicates, and no new safety or effectiveness questions were raised by the design differences.