See Instructions for Use packaged with Perfuze products for complete instructions on device usage.
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
United States: Rx only.
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. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The Perfuze Aspiration Tube Set is indicated to connect the Millipede 070 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.