Stent Retrievers
Tigertriever Revascularization Device
Indications for Use
The Tigertriever Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke 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
- Stentriever comprised of adjustable nitinol braided mesh
- Stainless steel shaft
- Nitinol core wire
- Handle with slider activation for manual expansion
- Radiopaque wires in mesh for fluoroscopic visualization
- Design optimized to penetrate and encapsulate thrombus
- Standard version (Tigertriever, TRPP7155): net length 32 mm (unexpanded), delivered through 0.021-inch microcatheter
- Tigertriever 17 version (TRPP7166): net length 23 mm (unexpanded), delivered through 0.017-inch microcatheter
- Provided with 3.5 Fr peelable loading sheath
- Distal OD (expanded configuration): 3 mm for Tigertriever 17, 6 mm for Tigertriever
- Stent length (unexpanded configuration): 23 mm for Tigertriever 17, 32 mm for Tigertriever
- Overall length: 200 cm
- Close-end braided nitinol mesh, manually expandable
- Materials: Nitinol stent, 90% Platinum/10% Iridium markers
- Core wire (shaft): Nitinol core wire and stainless steel shaft
- Push wire shrink tubing: PTFE
- Introducer sheath: PTFE
- Single use device
- Sterilization method: Ethylene oxide
- Shelf life: 2.5 years
- Radial force comparable to predicate device in applicable lumen diameters
- Durability: Acceptable performance for 3 passes
- Torque strength: Withstands 5 rotations without damage
- Dimensions within predicate range
- Tip flexibility: Meets acceptance criteria based on comparable devices
- Kink resistance: Acceptable under simulated anatomic tortuosity
- Tensile strength: Meets ISO 10555-1 standards
- Particulates generated similar to predicate device
- Austenite Finish (Af) temperature meets acceptance criteria
- Coating integrity: No damage following simulated use
- No corrosion observed per ISO 10555-1
Description
The Tigertriever device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, nitinol core wire and a handle. The shaft connects the mesh and the handle by the core wire that runs inside the shaft from the distal end of the mesh to the slider activation element in the handle. The mesh is expanded when the physician pulls the slider, since the wires of the mesh are completely radiopaque, the physician sees the mesh under fluoroscopy and controls it until it conforms to the vessel diameter. The design of the wire mesh is optimized to penetrate the clot and encapsulate it during retrieval. Two versions of the device are available. The standard version Tigertriever (TRPP7155) has a net length of 32mm (unexpanded form) and it is delivered through a microcatheter with an internal diameter of 0.021 inches. The shorter version Tigertriever 17 (TRPP7166) has a net length of 23 mm (unexpanded form) and it is delivered through a microcatheter with an internal diameter of 0.017 inches. The Tigertriever is provided with a 3.5 Fr peelable loading sheath.