Riptide Aspiration System
Micro Therapeutics Inc. d/b/a ev3 NeurovascularThe Riptide Aspiration System is a medical device designed to restore blood flow in patients suffering from acute ischemic stroke caused by intracranial large vessel occlusions. It uses continuous aspiration via specialized catheters and pumping system to remove blood clots from critical arteries in the brain, helping clinicians quickly reopen blocked vessels and potentially improve patient outcomes.
Intended Use
The Riptide Aspiration System is intended for use in the revascularization 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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
Technology
The system comprises React 68 and React 71 catheters, large bore aspiration tubing, an aspiration pump, and collection canister with tubing. It operates by continuous aspiration to remove clots from large intracranial vessels. Components are made of medical grade plastics and metals with hydrophilic coatings; the pump provides vacuum suction with a range of 0-29 inHg and flow rate up to 0.8 SCFM. Electrical safety and medical suction compliance are confirmed per IEC and ISO standards.
Performance
Non-clinical bench testing and design validation performed, including electrical safety, electromagnetic compatibility, medical suction tests, and usability engineering assessments. No clinical testing changes were necessary as the device maintains the same intended use and technology from predicate. Testing confirmed substantial equivalence and safety.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/30/2024
29 days - 2
FDA Approval
10/29/2024
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