Aspiration Catheters
CEREGLIDE™ 42 Intermediate Catheter; CEREGLIDE™ 57 Intermediate Catheter
Indications for Use
The CEREGLIDE 42 Intermediate Catheter and the CEREGLIDE 57 Intermediate Catheter, with the Cerenovus Aspiration Tubing Set and a compatible aspiration pump, are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment. The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter or the CEREGLIDE™ 71, 57 or 42 Intermediate Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.
Key Specifications
- Variable stiffness, single lumen catheter designed for introduction over a steerable guide wire or microcatheter into the neurovasculature
- Shaft composed of stainless-steel variable pitch braid with PTFE inner liner
- Exterior covered with polymer materials (Pebax, Urethane) encapsulating the braid
- Stiff proximal shaft transitioning to flexible distal shaft
- Distal end features radiopaque marker band (Platinum/Iridium) and hydrophilic coating for lubricity (coating length: 55 cm)
- Non-shapeable tip configuration
- Proximal end has luer fitting for flushing and aspiration, with ID band over strain relief
- Packaged with Tuohy Borst Rotating Hemostasis Valve (RHV) with side port and two slit introducers
- Intended for thrombus removal using continuous aspiration from external vacuum source
- Compatible aspiration pump requirements: minimum vacuum -68 kPa (-20 inHg), maximum -95 kPa (-28 inHg), minimum flow rate 17 L/min, collection canister ≥1000 mL
- Cerenovus Aspiration Tubing Set: ID 0.110”, length 112”, integrated flow control switch
- CEREGLIDE 42 lengths: 115 cm, 125 cm, 132 cm, 144 cm, 152 cm, 160 cm; ID: 0.042”; Distal OD: 0.053” (1.35 mm); Proximal OD: 0.0535” (1.36 mm)
- CEREGLIDE 57 lengths: 115 cm, 125 cm, 132 cm, 137 cm; ID: 0.057”; Distal OD: 0.068” (1.73 mm); Proximal OD: 0.0685” (1.74 mm)
- Sterilization: Ethylene Oxide (EO), Sterility Assurance Level (SAL): 10-6
- Shelf life: 3 years
- Single use only
Description
Both the CEREGLIDE™ 42 Intermediate Catheter and CEREGLIDE™ 57 Intermediate Catheter are variable stiffness, single lumen catheters designed to be introduced over a steerable guide wire or microcatheter into the neuro vasculature. The catheter shaft is composed of a stainless-steel variable pitch braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with polymer materials, which encapsulate the stainless-steel braid construction. The catheter has a stiff proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The distal end of the catheter has a radiopaque marker band to facilitate fluoroscopic visualization and has a hydrophilic coating to provide lubricity to reduce friction during navigation in the vasculature. The proximal end of the catheter has a luer fitting located on the end of the catheter hub which can be used to attach accessories for flushing and aspiration. An ID band is placed at the distal end of the hub over a strain relief. The catheter is packaged with a Tuohy Borst Rotating Hemostasis Valve (RHV) with a side port and two slit introducers as accessories. The RHV with side port is used for flushing, insertion of catheters, and connection to an external aspiration system. The slit introducers are designed to introduce the catheter into the base catheter and protect the distal tip of the catheter during insertion into the RHV of the base catheter. The CEREGLIDE™ 42 Intermediate Catheter and the CEREGLIDE™ 57 Intermediate Catheter are designed for use in the removal of thrombus from the neurovasculature using continuous aspiration from an external vacuum source. The CEREGLIDE™ 42 Intermediate Catheter and CEREGLIDE™ 57 Intermediate Catheter are intended to be used with a compatible aspiration pump as a vacuum source that provides a minimum vacuum pressure of -68 kPa [-20 inHg] and a maximum vacuum pressure of -95 kPa [-28 inHg], and minimum 17 L/min flow rate, with a collection canister of at least 1000 mL volume. The CEREGLIDE™ 42 Intermediate Catheter and the CEREGLIDE™ 57 Intermediate Catheter are intended to be connected to the vacuum source using the Cerenovus Aspiration Tubing Set which is an externally manufactured tubing set with an internal diameter (ID) of 0.110” and overall length of 112”, containing an integrated flow control switch.