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

The Symphony Thrombectomy System is a catheter-based device designed to remove fresh blood clots (emboli and thrombi) from blood vessels using controlled aspiration. The standard system includes 16F and 24F catheters for use in peripheral blood vessels and pulmonary embolism treatment. A specialized 16F 82cm variant is available for peripheral vasculature only, excluding pulmonary use.

Both subject and predicate devices use single-lumen intravascular catheters with radiopaque markers and hydrophilic coating, sterilized via ethylene oxide. Key difference: subject device catheters have 13-month shelf life versus 7 months for predicate catheters. Both employ over-the-wire design with aspiration pump technology and identical materials (medical-grade plastics and metals), dimensions, and control mechanisms.

ISO 11135 (ethylene oxide sterilization validation), ASTM F1980 (accelerated aging testing), and VARC-2 bleeding classification criteria. Testing conducted in compliance with GLP regulations (21 CFR Part 58).

The subject devices share identical intended use, operating principle (aspiration-based thrombus removal), design concept, sterilization process, and product codes with predicates. Shelf-life extension was supported by new accelerated aging validation. Additional bench testing (kink radius, torque strength, lumen integrity, simulated use, particulates, coating integrity) and a GLP animal study confirmed safety for pulmonary embolism indication. Clinical SYMPHONY-PE study (109 subjects) demonstrated primary efficacy (RV/LV reduction 0.44, p<0.001) and safety (48-hour MAE 0.9%, p<0.001) meeting pre-specified performance goals, with no new safety or effectiveness questions identified.