Tigertriever 25 Revascularization Device

The Tigertriever 25 Revascularization Device is a stentriever (mechanical thrombectomy device) designed to restore blood flow by removing blood clots from large intracranial vessels in patients experiencing ischemic stroke within 8 hours of symptom onset. It is intended for patients ineligible for or who failed thrombolytic drug therapy.

The device is a stentriever comprising adjustable nitinol braided mesh, stainless steel shaft, nitinol core wire coated with PTFE, and a handle. Key differences from the predicate (Tigertriever 21) include a longer stent length (53 mm vs. 32 mm), larger expanded outer diameter (7.5 mm vs. 6 mm), larger microcatheter compatibility (0.025 inches vs. 0.021 inches), and fewer accessory sheaths (2 vs. 3). Materials, sterilization method, and single-use design remain identical.

ISO 13485 (design controls, nonconforming product, corrective/preventative action), ISO 10993 (biocompatibility), ISO 11135:2014/AC:2014 (ethylene oxide sterilization), ISO 11070:2014 (corrosion resistance), ASTM hemolysis study, and USP pyrogen testing. Performance testing included simulated use, radial force, durability, delivery/deployment/retrieval forces, torque strength, dimensions, tip flexibility, kink resistance, tensile strength, particulate evaluation, coating integrity, and usability testing.

The Tigertriever 25 has the same intended use, indications for use, and principles of operation as the predicate Tigertriever 21. The technological differences do not raise new questions of safety or effectiveness. Non-clinical bench testing, biocompatibility testing, and a GLP preclinical swine study demonstrated comparable safety, thromboresistance, clot retrieval performance, and minimal arterial changes versus the reference device, confirming substantial equivalence.