Stent Retrievers
pRESET Thrombectomy Device
Indications for Use
1. The pRESET® Thrombectomy 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 thrombolytic therapy. Endovascular therapy with the device should be started within 6 hours of symptom onset. 2. The pRESET® Thrombectomy 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 thrombolytic therapy or who fail thrombolytic therapy are candidates for treatment.
Key Specifications
- Sizes: 4x20mm, 5x40mm, 6x30mm
- Retrieval Structure: Nitinol
- Markers: Platinum/Iridium
- Push Wire: Stainless Steel
- Shrink Tubing: PTFE
- Designed for use in large vessels such as internal carotid artery (ICA) and middle cerebral artery (MCA)
- Supplied sterile and intended for single use only
- Sterilization Method: Ethylene Oxide
- Packaging: Stored within dispenser coil, Tyvek pouch, and shipping carton
- Radiopaque proximal and distal ends
- Kink resistant design
- Principle of Operation: Mechanical removal of thrombus to restore blood flow
Description
The pRESET® Thrombectomy Device is designed to restore blood flow in the neurovasculature by mechanical removal of thrombus in patients experiencing acute ischemic stroke due to large vessel occlusion with thrombus. The device is designed for use in large vessels of the neurovasculature such as the internal carotid artery (ICA) and the middle cerebral artery (MCA). The device is supplied sterile and intended for single use only.