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The Riptide™ Aspiration System is intended for use in the revascularisation of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the 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.
The Riptide™ Aspiration System is comprised of the following devices:
The Riptide™ Aspiration System is designed to remove occlusive thrombus from the cerebral vasculature using continuous aspiration. The catheter shaft has a hydrophilic coating that spans the distal 40 cm to reduce friction during use. The catheter acts as a conduit for providing direct aspiration to the occlusion site generated by the Riptide™ Aspiration Pump. The catheter is introduced through a guide catheter or sheath and into the intracranial vasculature and guided over a neurovascular guidewire and/or microcatheter to the site of the primary occlusion. The catheter is connected to the Riptide™ Aspiration Pump through the aspiration tubing. The Intermediate Tubing connects the Riptide™ Collection Canister to the Riptide™ Aspiration Pump. The Riptide™ Aspiration System in this configuration may be used to aspirate thrombus from the occluded vessel.
Note: The catheter and aspiration tubing are Applied Parts.
There are no known contraindications.
Introducer sheath size and maximum guidewire diameter are indicated on the product label.
Possible complications include, but are not limited to, the following:
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events.