Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
Perfuze Ltd.The Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set are medical devices designed to assist in the revascularization of patients experiencing acute ischemic stroke caused by large vessel occlusions in the brain. The catheter is used alongside a compatible aspiration pump to remove blood clots from the affected neurovasculature, helping to restore blood flow. This device is intended for use within 8 hours of stroke symptom onset and for patients who have not responded to or are ineligible for thrombolytic drug therapy.
Intended Use
The Millipede 070 Aspiration Catheter, with the Perfuze Aspiration Tube Set and a compatible aspiration pump, is indicated 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.
Technology
The Millipede 070 Aspiration Catheter is a sterile, single-use, single lumen reinforced catheter with hydrophilic coating for vascular navigation, featuring a radiopaque marker for fluoroscopy visualization. The Perfuze Aspiration Tube Set is a flexible braided tube connecting the catheter to an aspiration pump, enabling direct aspiration thrombus removal from neurovasculature.
Performance
The subject device shares the same indications, operating principle, and design as the predicate device; therefore, non-clinical bench testing was not required. Biocompatibility was confirmed based on identical materials. Sterilization validation was performed for the tube set with no new clinical or animal studies required.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/2/2025
1 month - 2
FDA Approval
2/26/2025
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