Esperance pHLO Aspiration System

The Esperance pHLO Aspiration System is a percutaneous catheter designed for mechanical thrombectomy in acute ischemic stroke patients with large vessel occlusions in the brain (internal carotid, middle cerebral M1/M2, basilar, and vertebral arteries) within 8 hours of symptom onset. It consists of a single-lumen flexible aspiration catheter, tubing set, and introducer sheath used to remove blood clots via vacuum aspiration.

The device features a stainless steel braided shaft with nitinol coil reinforcement, polymeric exterior, and a radiopaque platinum/iridium marker band. It differs from the predicate (Esperance Aspiration Catheter K211697) primarily in the catheter's braided shaft material (stainless steel vs. nitinol) and extended hydrophilic coating length (100 cm vs. 60 cm). Both devices are 6F outer diameter with comparable inner diameters and working lengths of 125–135 cm.

Testing referenced ISO 10993-1 (biocompatibility), ISO 10555-1 (intravascular catheters), ISO 80369-20 and ISO 80369-7 (connector testing), ISO 62366-1 (usability engineering), EN ISO 11135:2014 and AAMI TIR28:2009 (ethylene oxide sterilization), and FDA guidance documents on guidewires, PTCA catheters, human factors, and shelf-life.

Phenox Ltd. demonstrated substantial equivalence by showing the pHLO device has identical intended use, similar technological characteristics and materials, and the same mechanical thrombectomy operating principle as the predicate Esperance Aspiration Catheter (K211697). All bench performance tests (trackability, aspiration flow, torque, kink resistance, burst pressure, etc.) met acceptance criteria comparable to the predicate, and comprehensive biocompatibility testing showed no new safety concerns. No clinical or animal testing was required.