Stent Retrievers
Trevo ProVue and XP ProVue Retrievers
Indications for Use
The Trevo Retrievers are indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset.
Key Specifications
- Flexible, tapered core wire with shaped self-expanding section at distal end for clot capture and removal
- Radiopaque platinum wires in shaped section and radiopaque markers on distal end for fluoroscopic visualization
- Hydrophilic coating to reduce friction during use
- Delivered to occlusion site through microcatheter
- Torque device for locking core wire to microcatheter, allowing retraction as a system through guide catheter
- Insertion tool provided
- Configurations include Trevo XP ProVue 3x20, 4x20, 4x30, 6x25 and Trevo ProVue 4x20
- Sterile for single use, sterilized by ethylene oxide (EO) with SAL of 10-6
- Shelf life of 24 months, supported by accelerated and real-time testing
- Biocompatible for external communicating devices of limited contact duration (<24 hours)
- No new materials introduced; leverages prior biocompatibility data
Description
The Trevo ProVue and XP ProVue Retrievers consist of a flexible, tapered core wire with a shaped self-expanding section at the distal end for clot capture and removal. Radiopaque platinum wires in the shaped section and radiopaque markers on the distal end allow fluoroscopic visualization. The Trevo Retrievers have a hydrophilic coating to reduce friction during use. A torque device and an insertion tool are provided with the Retrievers. The Trevo Retrievers are delivered to the site of occlusion in the neurovasculature through a microcatheter. The torque device may be used to lock the core wire of the Trevo Retriever to the microcatheter during the procedure, allowing the Trevo Retriever and microcatheter to be retracted as a system through the guide catheter and removed from the body with captured clot.