FDA Approves MicroVention’s Neuro Stent Devices

MicroVention Inc., a U.S.-based subsidiary of Terumo and a global neurovascular company, announced the FDA Premarket Approval (PMA) for the LVIS and LVIS Jr. stents for stent-assisted coil embolization of intracranial aneurysms. The LVIS and LVIS Jr. stents are the first and only stents PMA approved for stent-assisted coil embolization 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 visualization to provide support for even the smallest neurovascular embolization 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 Dr. David Fiorella, Professor of Neurological Surgery and Radiology, Director of Neurointerventional Radiology, Co-Director of Stony Brook University Cerebrovascular and Stroke Center 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.
 
“The LVIS and LVIS Jr. stents address the growing preference of physicians for highly conformable braided stents for aneurysm treatment. Thousands of patients globally have benefited from this technology, and we are pleased to have achieved the most rigorous standard of FDA approval to support our customers’ usage,” said Richard E. Cappetta, president and CEO, MicroVention Inc.
 
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 hemorrhage (SAH) and are prone to acute re-bleeding with poor clinical outcomes despite current surgical or endovascular treatment.