Aspiration Catheters
Esperance 3+ Aspiration Catheter System
Indications for Use
The Esperance 3+ Aspiration Catheter with the Wallaby Aspiration Tubing set and a compatible aspiration pump is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Key Specifications
- Single-use, vascular catheter with single lumen and variable stiffness composite construction
- Tapered shaft: inner diameter (ID) from 0.054'' proximal to 0.041'' distal
- Tapered outer diameter (OD) from 0.066'' proximal to 0.050'' distal
- Working lengths: 120 cm, 133 cm, 145 cm, 153 cm, 160 cm
- Supplied as a kit with Wallaby Aspiration Tubing Set (112 inch length, ID 0.110 inch, materials: Polyurethane & Nylon, integrated valve for vacuum control)
- Distal tip radiopaque and visible under fluoroscopy
- External hydrophilic coating on distal shaft (100 cm length) to reduce friction
- Proximal end features strain relief (silicone) and standard luer adapter
- Semi-rigid proximal shaft transitioning to flexible distal shaft for tortuous anatomy navigation
- Inner shaft: stainless steel braided shaft, Nitinol coil
- Outer layer materials: Tecoflex (thermoplastic polyurethane), Pellethane (thermoplastic polyurethane), Pebax (polyether block amide), Vestamid (polyamide)
- Inner layer: PTFE
- Wire reinforcement: stainless steel braided shaft, Nitinol coil
- Tip configuration: straight, steam shapeable by user
- Marker band: radiopaque Platinum/Iridium
- Hub material: polyamide
- Colorant: Green/Blue/White
- Accessories: Introducer Sheath, Shaping Mandrel, Rotating Haemostasis Valve
- Sterilization: Ethylene Oxide (SAL 10-6)
- Shelf life: 12 months
- Packaging: HDPE packaging hoop within sterile barrier Tyvek to nylon pouch, shipping carton
- Non-active, surgically invasive device for short-term neurovasculature use
- Class II, Product Code: NRY, Regulation: 21 CFR 870.1250
Description
The Esperance 3+ Aspiration Catheter is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. The device has a tapered shaft with tapered inner diameter (ID) from 0.054’’ (proximal) to 0.041’’ (distal) and tapered outer diameter (OD) from 0.066’’ (proximal) to 0.050’’ (distal). It has five different working lengths: 120 cm, 133 cm, 145 cm, 153 cm, and 160 cm. The device is supplied as a kit with the Wallaby Aspiration Tubing Set provided with a single catheter. The distal tip of each catheter is visible under fluoroscopy and the distal shaft of each catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of each catheter incorporates a strain relief and a standard luer adapter to facilitate the attachment of accessories. Each catheter has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous anatomy. The Esperance 3+ Aspiration Catheter System is a non-active, surgically invasive device intended for short term use within the neurovasculature.