Liberant Thrombectomy System

The Liberant Thrombectomy System is a mechanical aspiration device designed to remove fresh, soft blood clots from peripheral arteries and veins. It consists of a single-use catheter set (including catheter, clotbuster, dilator, and tubing) paired with reusable capital equipment (a blood conservation unit and aspiration pump) that generates vacuum suction to extract thrombus material.

The device uses continuous aspiration via a vacuum source to remove emboli and thrombus, with a clotbuster tool (rather than a separator) supplied with the catheter to clear blockages. It offers the same catheter sizes (6F, 8F, 12F), lengths, and 0.035-inch guidewire compatibility as the predicate Indigo Aspiration System. Minor differences include clotbuster lengths optimized for the Liberant design and shorter shelf life (6 months vs. 36 months for the predicate).

Biocompatibility testing per ISO 10993-1 (cytotoxicity, systemic toxicity, intracutaneous irritation, skin irritation, acute systemic toxicity, sensitization, and hemocompatibility assays). Sterilization via ethylene oxide; also software validation and electrical/electromagnetic compatibility testing performed.

The Liberant and Indigo systems share identical indications, classification, aspiration-based operating principle, and key design parameters (catheter sizes, lengths, guidewire compatibility, biocompatibility standards). While the Liberant uses an integrated clotbuster instead of a separate separator and includes a reusable blood conservation unit, these are minor design variations that do not alter the fundamental continuous aspiration mechanism or intended clinical use. Non-clinical performance and biocompatibility testing demonstrate equivalent safety and effectiveness profiles.