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Millipede88 Aspiration Catheter
As part of the Millipede System, the Millipede88 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 artery and middle cerebral artery M1 segment within 8 hours of symptom onset. Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment.

Millipede70 Aspiration Catheter
As part of the Millipede System, the Millipede70 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. Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment.

Perfuze Aspiration Tube Set
As part of the Millipede System, the Perfuze Aspiration Tube Set is indicated to connect the Millipede88 or Millipede70 Aspiration Catheter to a compatible aspiration pump.

The Millipede System is comprised of the Millipede88 Aspiration Catheter, the Millipede70 Aspiration Catheter and the Perfuze Aspiration Tube Set.

The Millipede88 and Millipede70 Aspiration Catheters are single-lumen, reinforced, variable stiffness catheters. Both have a hydrophilic coating on their outer surface at the distal end (distal 350 mm of the Millipede88 Aspiration Catheter and distal 500 mm of the Millipede70 Aspiration Catheter) to enhance tracking through the vasculature. A radiopaque marker provides the user with visual confirmation of the distal tip location under fluoroscopy. Both catheters are supplied with a rotating hemostasis valve (RHV). The RHV is designed to be attached to the proximal hub of the catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of devices into the catheter.

The Millipede88 Aspiration Catheter is also supplied with a valve crossing tool. The valve crossing tool is included to facilitate insertion of the Millipede88 Aspiration Catheter through an access sheath with a cross-cut valve. The valve crossing tool is not required if the access sheath has an RHV.

The Perfuze Aspiration Tube Set is a sterile, single-use device consisting of a single flexible braided tube. The tube has a rotating male luer-lock connector on the distal end and a suction connector on the proximal end. The rotating male luer-lock connector connects to the hub of the Millipede88 or Millipede70 Aspiration Catheter. The suction connector connects to the canister of an aspiration pump. A pinch clamp provides the user with the ability to apply vacuum to the catheter.

For the aspiration source, the Millipede88 and Millipede70 Aspiration Catheters are used in conjunction with a compatible aspiration pump with prespecified performance parameters along with a legally marketed canister and accessories kit. The aspiration pump is connected to the aspiration catheter using the Perfuze Aspiration Tube Set.

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