Stent Retrievers
Solitaire™ X Revascularization Device
Indications for Use
1. The Solitaire™ X Revascularization Device is 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 be started within 6 hours of symptom onset.
2. The Solitaire™ X Revascularization Device is indicated 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 IV t-PA or who fail IV t-PA therapy are candidates for treatment.
3. The Solitaire™ X Revascularization Device is 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 of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (< 70 cc by CTA or MRA, < 25 cc by MR-DWI). Endovascular therapy with the device should start within 6-16 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.
2. The Solitaire™ X Revascularization Device is indicated 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 IV t-PA or who fail IV t-PA therapy are candidates for treatment.
3. The Solitaire™ X Revascularization Device is 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 of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (< 70 cc by CTA or MRA, < 25 cc by MR-DWI). Endovascular therapy with the device should start within 6-16 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.
Key Specifications
- Designed for use in neurovasculature including Internal Carotid Artery (ICA), M1 and M2 segments of the middle cerebral artery, basilar, and vertebral arteries
- Distal nitinol portion facilitates clot retrieval
- Platinum/Iridium radiopaque markers on proximal and distal ends
- Radiopaque markers along the circumference of the working length
- Supplied sterile and intended for single-use only
- Available sizes: 3-20-10 mm, 3-40-10 mm
- Stent material: Nitinol
- Pushwire material: Nitinol
- Markers: 90% Platinum / 10% Iridium
- Push-wire shrink tubing: PTFE
- Introducer sheath: Marlex 5502 / Orevac 18300 / Grilamid L25
- Packaging: Stored within dispenser coil, Tyvek/Nylon pouch, and shipping carton
- Sterilization method: Ethylene Oxide
- Distal finger markers: Platinum/Iridium Bands
Description
The subject 3 mm Solitaire™ X Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. It is intended for use in the neurovasculature such as the Internal Carotid Artery (ICA), M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries. The distal nitinol portion facilitates clot retrieval and has Platinum/Iridium radiopaque markers on the proximal and distal ends, with additional radiopaque markers along the circumference of the working length. The device is supplied sterile and intended for single-use only.