Click on the link below to download Instructions for Use.
Millipede 088 Aspiration Catheter
Europe: Millipede 088 is a Class III device CE-marked according to the Medical Device Directive 93/42/EEC (DQS Medizinprodukte GmbH, CE0297). Millipede 088 is indicated for the following uses:
- Introduction of contrast agent, guidewires and intravascular catheters to the neuro and peripheral vasculature.
- Introduction of mechanical thrombectomy devices to the neurovasculature.
- Removal/aspiration of emboli and thrombi from selected blood vessels in the neuro and peripheral vasculature.
United States: The Millipede 088 Aspiration Catheter is an investigational device that is limited by Federal (or United States) law to investigational use. Not available for sale.
Other Jurisdictions: The Millipede 088 Aspiration Catheter is not approved or cleared for market use in any jurisdictions outside Europe.
Millipede 088 Access Catheter
United States: Rx only. The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature.
Other Jurisdictions: The Millipede 088 Access Catheter is not approved or cleared for market use in any jurisdictions outside the United States.
Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
Instructions for Use
United States: Rx only.
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.
The Perfuze Aspiration Tube Set is indicated to connect the Millipede70 Aspiration Catheter to a compatible aspiration pump.
Other Jurisdictions: The Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set are not approved or cleared for market use in any jurisdictions outside the United States.
Zipline Access Catheter
United States: Rx only. The Zipline Access Catheter is indicated to facilitate the insertion and guidance of catheters into a selected blood vessel in the neurovascular system.
Other Jurisdictions: The Zipline Access Catheter is not approved or cleared for market use in any jurisdictions outside the United States.