Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy System

The Symphony Thrombectomy System is a peripheral vascular device designed to non-surgically remove fresh blood clots (emboli and thrombi) from blood vessels using controlled aspiration. It also permits injection, infusion, and aspiration of contrast media and other fluids. Two variants are cleared: the standard Symphony Thrombectomy System and the Symphony 16F 82cm Thrombectomy System, which is a line extension with a slightly different catheter length (86 cm vs. predicate lengths of 121 cm for 16F and 85 cm for 24F).

Both subject devices use the same single-lumen intravascular catheter design, over-the-wire thrombus removal mechanism, and continuous aspiration pump as the predicate. Key differences include extended shelf life (7 months vs. 3 months for catheters; 25 months vs. 7 months for ProHelix), addition of a Symphony Clot Container in accessories, and for the 16F 82cm variant, a catheter length of 86 cm instead of 121 cm. All other components, materials, sterilization method (ethylene oxide), coatings, and operating principles remain identical.

ISO 11135 (Ethylene Oxide sterilization validation per overkill method); ASTM F1980 (accelerated aging testing for shelf life); IEC and biocompatibility testing per GLP regulations 21 CFR Part 58. Biocompatibility included cytotoxicity, hemocompatibility, FTIR, and SEM analysis.

The subject devices meet substantial equivalence because they share identical indications for use, design concept, operating principle, and sterilization method as the predicate. Bench and laboratory testing of the subject devices (including visual/dimensional verification, kink/bend, actuation force, tensile/torque strength, pressure/leak, fatigue, and characterization tests) demonstrated all acceptance criteria were met. Where differences exist—such as extended shelf life and the addition of the clot container—risk assessments determined these do not raise new safety or effectiveness questions. Prior predicate testing (lumen integrity, burst pressure, fluoroscopy visibility, simulated use, corrosion resistance, coating integrity, particulate) was evaluated for applicability. Biocompatibility testing confirmed non-cytotoxicity and non-hemolytic results, supporting equivalence without new safety concerns.