Lynx Aspiration Catheter System

The Lynx Aspiration Catheter System is a single-lumen, variable-stiffness catheter with hydrophilic coating designed to remove blood clots (thrombi) from brain blood vessels using suction. It is indicated for revascularization of acute ischemic stroke patients with large vessel occlusion in intracranial arteries within 8 hours of symptom onset, for patients ineligible for or failing thrombolytic therapy.

The Lynx shares the same fundamental design as predicate Penumbra Reperfusion Catheters: single-lumen variable-stiffness design, hydrophilic coating, radiopaque distal marker band, Platinum/Iridium marker, comparable inner/outer diameters (072/058/044 models), similar materials (stainless steel, nitinol, PTFE, polyurethane), and identical sterilization via ethylene oxide. The Lynx offers straight tip shape versus predicate shapeable tips.

ISO 10993-1 (biocompatibility), ISO 13485 (design controls and quality management), ISO 10555-1 (catheter testing), ISO 11135:2014 (sterilization validation), ISO 10993-7:2008 (residual sterilant limits), ISO 80369-7 (small bore connectors for intravascular use), and GLP animal testing in porcine models.

The Lynx is substantially equivalent because it has identical intended use, indications for use, fundamental design architecture, and technological characteristics as the predicate Penumbra devices (RED 72, RED 62, RED 43). Non-clinical testing demonstrates comparable safety and performance, including biocompatibility, sterility, mechanical properties, and animal study results showing equivalent vascular safety profiles. The minor differences (straight vs. shapeable tip, accessory variations) do not raise new safety or effectiveness questions.