Principal Investigator: Phil  Taussky
Keywords: LVIS , Intraluminal , MicroVention , Device Department: Radiology Clinical
IRB Number: 00077366 Co Investigator:  
Specialty: Neurosurgery
Sub Specialties:
Recruitment Status: Recruiting

Contact Information

Salman  Yakub

Brief Summary

The HDE is FDA approved.  This is a Humanitarian Use Device (HUD).  The name of the device is LVIS or Low-Profile Visualized Intraluminal Support. 

Inclusion Criteria

Patients who, in the investigator's opinion, are eligible for implantation of the LVIS Device.  It is intended for use with bare platinum embolic coils for the treatment of unruptured, wide neck (neck ≥ 4 mm or dome to neck ratio < 2), intracranial, saccular aneurysms arising from a parent vessel with a diameter ≥ 2.5 mm and ≤ 4.5 mm.



Exclusion Criteria

Use of the LVIS device is contraindicated under these circumstances:

 Patients in whom anticoagulant, anti-platelet therapy or thrombolytic drugs are contraindicated;

 Patients with known hypersensitivity to metal, such as nickel-titanium and metal jewelry; Patients with anatomy that does not permit passage or deployment of the LVIS device;

 Patients with an active bacterial infection;

 Patients with a pre-existing stent in place at the target aneurysm.