MicroVention has announced today the FDA Premarket Approval (PMA) for the LVIS and LVIS Jr. stents for stent-assisted coil embolisation of intracranial aneurysms. The LVIS and LVIS Jr. stents are the first and only stents PMA approved for stent-assisted coil embolisation and only the second PMA approved device designed for intracranial aneurysm treatment.
The LVIS and LVIS Jr. stents (Low profile Visualized Intraluminal Support) feature a braided conformable, resheathable and retrievable design that provides high metal coverage and end-to-end device visualisation to provide support for even the smallest neurovascular embolisation coils for the treatment of wide-necked saccular intracranial aneurysms.
“With their low-profile and consistent visibility, LVIS and LVIS Jr. stents expand the treatment options for patients with challenging, wide-necked aneurysms. The pivotal trial shows that these stents are safe and effective for patients with aneurysms that may be challenging to treat with other devices,” said David Fiorella, Professor of Neurological Surgery and Radiology, Director of Neurointerventional Radiology, Co-Director of Stony Brook University Cerebrovascular and Stroke Centre and primary investigator of the trial.
The LVIS and LVIS Jr. stents have been approved for use in the United States under Humanitarian Device Exemption (HDE) since 2014 and with the PMA approval, LVIS and LVIS Jr. stents may potentially be used to treat an increased number of patients.
An intracranial aneurysm is a bulging, weak area in the wall of an artery that supplies blood to the brain. Patients who present with a ruptured intracranial aneurysm may suffer a subarachnoid haemorrhage (SAH) and are prone to acute re-bleeding with poor clinical outcomes despite current surgical or endovascular treatment.