CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set
Cerenovus Inc.The CEREGLIDE 42 and 57 Intermediate Catheters, together with the Cerenovus Aspiration Tubing Set, are medical devices used to remove blood clots from large intracranial vessels during acute ischemic strokes. These catheters are navigated through the brain's blood vessels under fluoroscopic imaging to restore blood flow by aspirating clots, helping patients who cannot receive or have failed drug-based clot dissolving treatments.
Intended Use
The CEREGLIDE 42 and 57 Intermediate Catheters, with the Cerenovus Aspiration Tubing Set and a compatible aspiration pump, are indicated for use in revascularization of acute ischemic stroke patients with intracranial large vessel occlusive disease within 8 hours of symptom onset, including patients ineligible or failed thrombolytic therapy.
Technology
The catheters are variable stiffness, single lumen devices designed for neurovascular navigation over guide wires, featuring stainless-steel braid reinforcement, PTFE inner liners, hydrophilic coating for lubrication, and radiopaque markers for fluoroscopic visualization; they connect to aspiration pumps via an aspiration tubing set with integrated flow control to remove thrombus by continuous aspiration.
Performance
Extensive bench testing demonstrated that the catheters meet ISO standards for visual inspection, dimensional accuracy, leak integrity, kink resistance, tip stiffness, tensile strength, particulate count, burst pressure, torque strength, and trackability. In-vitro usability studies confirmed thrombus retrieval performance and device compatibility. No animal or clinical studies were required due to equivalency with predicate devices. The devices undergo validated ethylene oxide sterilization and have a shelf life of three years.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/1/2024
5 months - 2
FDA Approval
10/16/2024
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