Zoom System

The Zoom System is a catheter-based thrombectomy device for treating acute ischemic stroke caused by large vessel occlusions in the brain. It consists of aspiration catheters (Zoom 71, 55, 45, 35), large distal platform catheters, aspiration tubing, and a vacuum pump that work together to retrieve blood clots within 8 hours of symptom onset in patients ineligible for or unresponsive to intravenous thrombolytic therapy.

The subject Zoom Catheters share identical dimensions, materials, tip design, and sterilization methods with the predicate ZOOM Reperfusion Catheters. The LDP Catheters are identical to reference devices. The main difference is the Zoom POD Aspiration Tubing adds an in-line clot filter (collection pod) compared to the predicate tubing, which had no filter. All catheters use the same medical-grade polymers with hydrophilic coating and are sterilized via ethylene oxide to a 10⁻⁶ SAL.

ISO 10555-1 (catheter performance), ISO 10993-1 (biocompatibility evaluation and testing), ISO 11135 (ethylene oxide sterilization validation), ASTM F1980 (accelerated aging testing), and ISO 80369-7 (luer compatibility). Devices were tested for trackability, flexibility, burst pressure, coating integrity, vacuum force delivery, and clot retrieval performance.

The predicate and subject devices share the same indications for use, intended mechanism (aspiration thrombectomy), and core design—single lumen catheters with braid/coil reinforcement, hydrophilic coating, and identical dimensions and materials. Bench testing confirmed equivalent performance in delivery, flexibility, burst resistance, and vacuum force at the catheter tip. The addition of an in-line clot filter to the POD tubing was evaluated via biocompatibility testing (cytotoxicity, sensitization, irritation) and confirmed to introduce no new safety concerns. Clinical data from the Imperative Trial (211 subjects, 84% reperfusion success rate, 0.9% symptomatic ICH) demonstrated safety and effectiveness comparable to the predicate device's historical performance, meeting all pre-specified performance goals.